If a Device Does Not Require DM, is it Acceptable to Only Have the UDI on the Package Label?

The Unique Device Identification (UDI) must always be carried on the product label - so it depends on whether the information on the device constitutes a label. The Direct Mark (DM) requirements only come into play if your device meets the criteria for direct marking.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Are Salesforce Patches Pushed Directly to Production or Can Changes Be Tested First?

Salesforce.com patches are pushed directly to the production environment, unlike releases. You get informed of what they are and what they affect.

The patches have already been tested to make sure they don’t affect specific configurations. Typically, they do not affect anything internal from your own configurations as well. But, it is best to analyze the patch and determine whether to regression test it.  Patches can be regression tested very quickly, especially if you have an automated tester. For most patches, it is possible to determine using your change control processes that they have no effect on anything preexisting.

USDM Life Sciences specializes in providing answers and solutions for life sciences companies looking to move their software and servers to the Cloud. In fact, many of the largest software and hardware companies in the world come to USDM Life Sciences for best practices in the Cloud.  As a recognized global leader in life sciences compliance, USDM Life Sciences Cloud Solutions and Services.

What Types of Cloud ECM (Enterprise Content Management) Systems Are Available Right Now for Clinical Solutions?

There are a few cloud based ECM products out there. Alfresco provides cloud-based usage solutions that are smaller, more scalable solutions. Escort Viva is a giant in this space; They have been the front runner and have been providing a compliant cloud solution. Box and Drop Box provide cloud-based ECM solutions, but they are not Part 11 compliant and do not follow GxP standards at this point, will in the future. Ideally, once they are compliant, they can be used for business operations.

The USDM Life Sciences Clinical Services and Solutions team provides our clients (from start-up Biotech to large Pharma/Device) with the latest technology, processes and strategies to assist with efficiency, quality and compliance in any scenario and offers our clients a cost-effective, proactive and unified partnership in goal achievement.

How Do Life Science Companies Qualify Vendors and Software?

Vendor Qualification is going to depend on your own requirements. You need to establish that the vendor meets the requirements of your Service-Level Agreement (SLA).

What goes in the SLA is important and it needs to have an appropriate level of documentation, processes, and experience around infrastructure. Good qualification, data centers, and security procedures need to be formally documented and approved. Verify that there are redundancies in place such as correct document management systems, disaster recovery systems, and back-up systems.

Vendor Qualification can be viewed in two ways. You can either preform vendor audits to specify that you need these items or to find out if they have them, or you can engage other companies to do that for you. You can state in your SLA that the vendor must have these items in place in order to be considered a vendor.

There are three factors to consider. First, the Systems Qualification can be leveraged by the vendor’s efforts that they have already done from a qualification and a maintenance perspective. Next, do your validation the same as a hosted system with functional requirements and testing those according to risk. The third piece revolves around maintenance. It includes analyzing the communications that come out on a periodic basis to make sure that the risks are mitigated according to the testing.

ServicMax has a vendor audit program internally that can be provided to clients that are in a regulated industry. Clients have used them and all of the good manufacturing or good software development practices are all documented for use in that qualification or vendor audit process.

The USDM Life Sciences Cloud Practice is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.

What Are Some Challenges to Implementing a Clinical ECM (Enterprise Content Management) Solution?

One of the challenges is the complex legacy architecture. There is an IT investment cost that generally can drive into the millions. Oftentimes, companies do not want to consider large content management solutions because they can be expensive. Nowadays, the average number of years it takes for ECM solutions to be fully implemented is somewhere between seven to nine years. Oftentimes, companies will go through personnel changes before the implemented solution is fully deployed.

The IT investments in this area are quite considerable.  Take time to consider as many scenarios as possible when choosing an ECM platform, as these systems are long term solutions.

The USDM Life Sciences Clinical Services and Solutions team provides our clients (from start-up Biotech to large Pharma/Device) with the latest technology, processes and strategies to assist with efficiency, quality and compliance in any scenario and offers our clients a cost-effective, proactive and unified partnership in goal achievement.

At What Point of Receipt Should Healthcare Providers Start the Traceability of a Medical Device?

The traceability should really start at the receiving dock so what's going to be a change within the provider is going to be when the sales reps bring in product and a provider takes it directly to the Operating Room or to the Cath-lab, there's going to be a little bit of a change there. That information really needs to be captured at the point of receipts and I know that's going to be difficult especially during off hours because we typically don't have somebody in receiving 24/7, but that's going to be again, looking at this as a program. Whoever is accepting that product needs to be able to scan that product into some kind of receipt - to say "okay, this is now in the facility. It doesn't appear to have been damaged. We've got it in the facility." The point of receipt, the best way, is going to be at the receiving dock, but second to that is going to be the training and education - have people in the OR, the Cath lab, wherever that area is. Scan that product if you know it will be in the institution.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

Do Low-Risk Items Require Validation?

USDM Life Sciences is not suggesting not to validate any of your low-risk requirements. The important aspect to remember is if your implementation processes are documented, sound, repeatable, and your vendor has evidence of all the testing that they've done, you may not need to test out of the box functionality items that are considered to be low risk.

If you have items that are not GxP or low-risk GxP, depending on its complexity and configuration, you may have some informal user acceptance testing. You can leverage your supplier’s testing to have confidence in certain areas of the system’s functionality. You know the system can add 2 + 2; therefore, writing new test scripts may not be necessary. You can call back on the supplier testing if need be.

The majority of minor low-risk user testing items are going to be part of end-to-end, formal PQ testing, or integration testing. You are going to capture the information during this part of the testing and can reference those items when needed. Essentially, it would be redundant to write a specific test focusing upon that particular requirement on its own.

The USDM Life Sciences Cloud Practice is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.

Are VAPs Targeted for Out of the Box Applications Built on Salesforce or Pre-Packaged Solutions Like Viva?

The USDM Validation Accelerator Pack (VAP) takes care of the core platform. Beyond that, specific configuration and customization will be related to your company and your own use cases and requirements. By creating new scripts as necessary or modifying existing ones, those requirements are added to the preexisting requirements in the VAP. Although it is not possible to anticipate a specific company’s requirements in a VAP, we do qualify that platform and add in the necessary pieces.

The USDM Life Sciences Cloud Assurance Validation Accelerator provides the components required to meet FDA regulatory requirements including 21 CFR Part 11. For more information visit:

http://usdm.com/validation-accelerator-packs/by-vendor/salesforce.html 

USDM Life Sciences specializes in providing answers and solutions for life sciences companies looking to move their software and servers to the Cloud. In fact, many of the largest software and hardware companies in the world come to USDM Life Sciences for best practices in the Cloud. As a recognized global leader in life sciences compliance, USDM Life Sciences Cloud Solutions and Services provide security, lower costs and ensure compliance.

For Class II DPM That Are Due In 2018, Would The Labeling (Carton, Etc) Used For This Product Need To Be Compliant In 2016 Or Would It Be On The Same Timeline As DPM – 2018?

The labeling UDI requirements are independent of the DM requirements. Therefore all Class II items, whether DM is required or not, must have their labels compliant by Sep. 24, 2016. The DM 'label' is not required to be compliant until Sep. 24, 2018 to allow additional time for implementation.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Do Internal Audits Focus on Agency Regulations and Compliance Items or Do They Focus on Other Things Too?

With internal audits you want to audit to particular regulations. If you are under International Organization for Standardization (ISO) or Good Manufacturing Practices (GMP) constraints you want to make sure you are touching on any regulatory or compliance issues that a costumer, the Food and Drug Administration (FDA), or any other international agency is going to look at. That being said, it is also very important to concentrate on other areas as well as it comes down to best practices. You should look at your controls in place for everything from training records to manufacturing plans to organization and how you manage inventory. Concentrate on the regulatory compliance but be sure to include every area in your internal audit. If there are other areas that you feel are non-compliant, it is still important to audit concentrating on those areas as a best practice.

Internal audits are extremely useful and can be a very effective management tool when done properly. Some companies don’t do them thinking that a customer audit is interchangeable with an internal audit. This is not the case because customer audits are focused on a particular process line or product. With an internal audit you need to cover your entire organization and process line.

We recommend and use the FDA Q 10 approach when you are doing audits of your key systems, lab system, quality system, or manufacturing system.  That’s the approach the FDA uses as well. The FDA Q 10 is the most effective approach for getting the maximum value out of your audit.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

What Can a Company Allow a Vendor to Perform, and What Must They Perform Themselves?

A lot of times, especially when developing high levels of controls, companies in the industry feel that they need to do testing themselves. More and more companies are outsourcing the testing.

The fact is, a trusted vendor can do the calibrations and qualifications. Very often, vendors are the ones that set specifications for qualifications, so they are the best people suited to test. Validation can be done by vendors or contractors.

Regardless of who does the work, the company itself is responsible for defending the work. The company is responsible for the pre-approval, review, and the final approval process. When it is all said and done, the company owns the information. Whether it is calibration, qualification, or validation, the company’s Quality Assurance team is responsible for making sure that work is acceptable no matter who executed it.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.

What is the Recommended Approach for Control of Non-Regulated Laboratory Instrumentation?

If it is a basic instrument, it is best to have it calibrated. It is important to have a set of requirements to say what calibration set test points and ranges are producing data that are considered valid, even if it's not going into a regulatory document or submission.

The same process is recommended with regards to qualification. It is best to have met manufacturer specifications before instrument installation. You should do some type of testing, make sure the software works and that it is installed properly; that would go for any basic laboratory equipment.

Lab Systems that are not validated nor regulated would not need extra documentation, but it is still a best practice to have requirements and testing around any software that was used in a lab for data security and data integrity reasons.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.

Are Physician Offices and Clinics Considered Dispensers Under the DSCSA?

Physician offices and clinics are considered a trading partner under the Drug Supply Chain Security Act (DSCSA) if they procure medications.  The source of procurement is responsible for meeting the DSCSA.  There are some exceptions for the electronic requirement for a physician’s office.  However, the purchaser of the pharmaceuticals that the physician is dispensing is responsible for meeting the DSCSA requirements.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Are Physician Offices and Clinics Considered Dispensers Under the DSCSA?

Physician offices and clinics are considered a trading partner under the Drug Supply Chain Security Act (DSCSA) if they procure medications.  The source of procurement is responsible for meeting the DSCSA.  There are some exceptions for the electronic requirement for a physician’s office.  However, the purchaser of the pharmaceuticals that the physician is dispensing is responsible for meeting the DSCSA requirements.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

FDA Warning Letter or Audit Failure: How Do You Balance Internal Resource’s Existing Commitments so Remediation Activities are Not Compromised?

In many cases we see that individuals involved in assisting with remediation have their own normal day jobs along with other duties and responsibilities. These individuals are often pulled into the project in a matrix type of organization. It is very important that commitments are obtained with the resources from the internal organization.  It is important to realistically commit a resource’s time. In order to support the remediation plan, which is the top priority, we recommend the organization bring in some extra contract support. This additional support will help manage some of the day-to-day duties and offload work normally completed by key subject matter experts involved in the remediation activities. It is normally the project manager’s responsibility to make sure the remediation plan has all the proper resource loading, resource assignments, and realistic commitments.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

Would an A/C Adapter That Can be Sold as a Replacement Need a UDI?

There are no hard and fast rules here. A manufacturer has to decide where certain things fit.Now, there are obviously certain accessories already identified though the classification regulations and through the product codes. So there are some things that we already know are accessories, where we don't have to guess whether ventilator tubing, for example, is an accessory. It's already identified as such.

It's a very small proportion of all of the parts that are out there are actually separately identified as accessories from a regulatory perspective. So some things we could probably look at easily and say they're not an accessory. So if we think about a replacement panel for the back of a device. Right? I think we could all look at that and go "Well, okay, that's a replacement panel. That has no effect on the performance of the device. It's a spare part or replacement part.” And on the other end, we can probably say pretty easily that something like ventilator tubing is an accessory.

In between there's this just enormous gray space. Jay Crowley, Vice President of UDI Services and Solutions and the architect of the UDI Rule says he just can't answer that question for medical device companies. You're going to have to decide by going through this process following whatever SOP you put in place and documenting this and we've used different processes with different sets of criteria, depending on the client. You're going to have to go through and decide whether something that is individually distributed is an accessory or is not. And Crowley thinks it's important to look not only at the actual words that are associated with it, but the intent of the Rule and how your customers are going to react to some things being UDI compliant and some things not.

Unfortunately, without a lot more information and understanding of your specific devices, again there are no hard and fast rules here, aside from things being obviously identified as accessories already from a regulatory perspective. It's really a process and each manufacturer needs to decide how this is going to work for them.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

How Much Historical Data Do Companies Need to Bring into a New Cloud Based System?

There is no single correct answer to how much data should be moved from an legacy application to the Cloud but let’s discuss the process for doing this.  You will first want to look at your organization’s historical data requirements.  For example, determine whether or not you will need the old data at your fingertips or if your users can look it up in the old system.  Some companies maintain access to the legacy system and keep older data on it. Next, do a data quality review to determine if your historical data is clean and/or valuable. You definitely don’t want to clutter the new system with bad data.  If older data is needed in the new system and it’s clean and valuable, by all means, work from a data migration plan and load it in.

The USDM Life Sciences Cloud Team is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.

FDA Warning Letter: If a Company Finds Other Areas of Remediation, Should They Communicate Them to FDA?

You do not need to communicate other areas of remediation to the FDA immediately. For instance, if you have a nine month plan and a couple months into it you find an area that you need to correct and a couple months after you find another area that you will remediate that wasn’t part of an initial finding either, you do not have to communicate all of that back to the FDA.  But, in your final report or your final statement back to the FDA you may want to include that information. Including your own findings shows that you are doing your own due diligence and that you have your own internal controls in place.

USDM had a large client that had some 483s around some computer systems validation. Part of the plan was to investigate the root cause and within that was a plan to look at all of their automated systems and find out the levels of validation, if there was any validation. We found many systems the investigator didn’t look at that were not validated. We corrected the specific automated system in ERP as part of the investigation but in our final statement to the FDA we included that we addressed other areas where we found a lack of validation.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

How Does UDI Traceability Work with the Distributor?

There isn't a requirement for full traceability like you will see in pharmaceuticals. There is a requirement for full identification through plan of use at the healthcare institutions. The distributors really don't have a traceability responsibility, they have a responsibility to ensure that only properly identified medical devices, as required by law, are continued through the supply chain.

There are specific requirements that manufacturers legislation mandates manufacturers be compliant by a certain date and those dates are already under way. For class 3 - September 2014, for class 2 and class 1 that are regulated by the sedation regulation - September 2015, with some extensions, but essentially 2015. The large remaining bulk of class 2 products - September 2016, and then the class 1 products - September 2018.

Those are the UDI Final Rule regulatory requirements. There are some exceptions for existing inventory and there are also some feature requirements for direct marking, but there isn't going to be a traceability process, such as you may see in pharmaceuticals. It will be a registration with the FDA and a identification consistent with UDI and then the ability to start adopting that as that flow starts in the healthcare institution. The legislation regulation is there, the UDI Final Rule with those dates rolling from September 2014. The product changes are on the label, the product effect is on the label, not in a transaction history or a pedigree type of traceability that's required on the pharmaceutical side.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

Should Implantable Medical Device Manufacturers be Working on a Direct Marking Solution?

There is no regulatory requirement for direct marking the UDI on implantable devices.  However, for some implants, the DM UDI will provide a way of identifying a device at the point of implantation.  However, the inability to DM an implant is not an exception to the overarching requirement to provide the UDI at the point of implantation.
1. Individually labeled sterile implants
2. UDI tag – remains on the individual implant until use
3. Direct Part Marking (DPM) – 2D barcode etched on implant
4. Inventory control sheets – use sheets to map and recording sheets contain the DI in barcode and human readable lot number may be directly marked on implant (can be recorded or photographed)
5. Mobile application – to support field replenishment – ties specific implant’s UDI to each tray/caddy and guides replenish activities
USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

What’s the Process for Validating Mobile Applications and Devices?

A mobile device validation process should be included with your main system validation plan.  It can be treated like its own mini risk based system validation with inclusion of the integrations to the parent platform or master system, such as Salesforce.  Initially you perform an IQ on your hardware and software for the device using the specified operating system, hardware, and software application versions that you want to use.  It’s best to prevent users from upgrading to newer versions of the operating system, but that is not always feasible.  If you can’t prevent users from upgrading, you want your training policies and standard operating procedures (SOPs) to state that users are not permitted to upgrade to the newest version of operating system.  You also want to make sure you do testing for the integration to the master system.  You also need to consider whether data updates will be synced in real time automatically, offline manually, or a combination of both for situations when a network isn’t always available.

The USDM Life Sciences Cloud Team is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.

How Far Back in the Supply Chain Does a Pharmaceutical Need to Be Traceable?

A pharmaceutical must have the ability to be traced back to the manufacturer.  For example, authorized distributors must have information on the TH (what is TH?) TH links the product back to the manufacturer.  If there is a change of ownership between the manufacturer and the authorized distributor, the manufacturer must appear on the TH.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

Can You Rank Suppliers in Categories Other Than Critical or Noncritical?

In order to determine the rank of a supplier it is important to take the risk-based approach. The FDA really promotes that as well as what they call “the least burdensome process”. Whether it is supplier qualification, computer system validation, cleaning validation, or process validation it is essential to take that risk based approach. Evaluate the risk to the product, the risk to patient safety, and all the safety quality identity purity potency.
 For example, a supplier of glass vials you will use for the final packaging of your biologics product is a much greater risk than the supplier doing your pest control.  A risk-based approach will allow you to determine the risk classification. Ranking a supplier depends on its criticality to your particular function for product. You could rank them within critical or non-critical but then within each you could have various time frames as far as on site or desk audits are concerned.
 Any associated activities whether it is frequency of auditing, frequency of validation, or periodic review should be scaled appropriately based on the risk. We suggest listening to the webinar on incorporating risks into the audit process. We are considered to be a thought leader in the life science industry and we are very eager to share our information on webinars.
USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

Is Data More Secure in the Cloud?

You’ve probably heard about people getting unauthorized access to a company’s data. If you have your own servers or use a third party data center, all your data resides in one place or cluster.  If a security breech happens and a hacker obtains access to your systems, they can usually get their hands on all of your data.  In the Cloud, your data is segmented into multiple servers around the country or even the world.  Gaining access to all your data in the Cloud is much more difficult than if it were stored in one system. This means that if a criminal gains access to your sensitive information in the Cloud, they would only get a small amount of data.

The USDM Life Sciences Cloud Team is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.

Are there DSCSA Solutions Built on EPCIS Standards?

There are Drug Supply Chain Security Act (DSCSA) solutions built on the EPCIS set of messaging standards being used in production.  An Internet search for EPCIS will help you locate EPCIS vendors.  This is not a concept that is future state.  There are companies using this method every day, including some with serialized products.
Most vendors can handle EDI and EPCIS, but keep in mind the limiting factor for any of the technologies you select is whether your customer can receive the data format.  According to the FDA guidance on the DSCSA, trading partners need to be interoperable – meaning they need to agree to use the same data format.  Grant Hodgkins, Vice President of Track and Trace Services and Solutions at USDM Life Sciences, says the pharmaceutical industry and FDA need to partner to better define what interoperability between trading partners means.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.  

What Kinds of Cloud ECM Systems are Available Right Now for Clinical Solutions?

For cloud-based Enterprise Content Management (ECM), there are a few products out there. There's Escort Viva, that's a giant in this space. They've actually been the front runner in providing the compliant cloud solution. You have probably heard of Box and Dropbox. They provide cloud-based ECM solutions, but those aren't GxP capable right now. They're not compliant and don't follow GxP standards at this point, but they will in the future.

The USDM Life Sciences Clinical Services and Solutions team provides our clients (from start-up Biotech to large Pharma/Device) with the latest technology, processes and strategies to assist with efficiency, quality and compliance in any scenario and offers our clients a cost-effective, proactive and unified partnership in goal achievement.

Is It Recommended or Required to Register for ISBT 128 for a Device with Human Cells, Tissues, and Cellular Tissue-Base Product (HTC/P)?

It is not a requirement; it is a recommendation. There are many advantages for using ISBT 128 for HTC/P, the most important of which is the distinct identifier that identifies all tissues from a given donor. This unique identifier allows rapid recall of products should a problem with the donor be discovered after distribution of products.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Validate Salesforce: Once Core Platform is Validated, Do I Redo Validation for Each New GxP Application I Add?

After you validate the initial core platform, revalidating the entire platform as you add applications is not necessary; validation can be done on a risk-based perspective. Only the new piece of functionality must be validated. Any touch points according to your configuration managing process and risk assessment must be checked in order to ensure they have not been affected.

USDM Life Sciences specializes in providing answers and solutions for life sciences companies looking to move their software and servers to the Cloud. In fact, many of the largest software and hardware companies in the world come to USDM Life Sciences for best practices in the Cloud.  As a recognized global leader in life sciences compliance, USDM Life Sciences Cloud Solutions and Services provide security, lower costs and ensure compliance.

Does the Drug Supply Chain Security Act (DSCSA) Require a Data Matrix on the Drug Package and the Product Label?

Grant Hodgkins, Vice President of Track and Trace Services and Solutions at USDM Life Sciences says it’s unclear how this is going to work with the barcode rule intact.  At the moment, if you have a drug package that is two levels (for example, a blister pack going inside a carton dispensed at a pharmacy), the linear would continue to go on the carton as well as a data matrix.  Hodgkins says there are all kinds of variances for this particular situation and the FDA will need to clarify the requirement for this type of situation.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

What are Some of the Tools That Can be Used for a Successful ECM Implementation?

Some of the tools you can use to help with Enterprise Content Management (ECM) implementation are project governance charts, project timelines, and responsibility matrices. Some of the other tools you can use are file sync and share solutions or anything to do with collaboration. Everything seems to be on the Cloud and externalized nowadays, so things like SharePoint 365 and VoxUltra provide external collaboration that will really help you with your implementations across any type of ECM implementation.

The USDM Life Sciences Clinical Services and Solutions team provides our clients (from start-up Biotech to large Pharma/Device) with the latest technology, processes and strategies to assist with efficiency, quality and compliance in any scenario and offers our clients a cost-effective, proactive and unified partnership in goal achievement.

FDA Waring Letter: What if a Company Needs More Time to Remediate a Problem

We can all estimate times and we have all been through projects that don’t end on the date or time expected. As long as you communicate, you will be fine.  If you have committed to a particular date on your 30-day response to a warning letter and you find that while you are remediating you need more time, you must communicate to the FDA. It’s not uncommon to have an initial timeline in place and then find you need additional time. You will be fine as long as you explain why you need more time, what the new time frame will be, and what the new risk factors involved are.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

Can You Use ISBT 128 for Non-Human Cells, Tissues, and Cellular Tissue-Base Product (HTC/P) Devices?

Generally speaking, you can’t use ISBT 128 for non-Human Cells, Tissues, and Cellular Tissue-Base Product (HTC/P) devices. There is one exception. You may use ISBT 128 for empty blood bags. We suggest people look at the Global Unique Device Identifier Database (GUDID) and Global Standards One (GS1) for anything that is not an HTC/P.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Is it Acceptable to Push Back if You Disagree with a Notice of Violation or 483?

It certainly is acceptable to push back, but you need to be able to do that in a professional and politically correct manner. The best way to do that is to push back during the course of the audit or while the inspection is still in progress. If the investigator indicates that he or she has a particular concern, it is important to first understand their concerns, make sure they are not misinterpreting your quality system or your process or procedure, and make sure you have presented all your appropriate artifacts and objective evidence.

USDM does this during readiness assessments to make sure that if there are any observations, issues, or concerns being raised that the organization has had every opportunity to present proper documents or proper objective evidence. The burden is on you to make sure that you are presenting your case and defending your procedure.  FDA investigators don’t go out of the way to ask you to present all of the evidence in support of your rationale, scientific justification, or basis for your process or procedure. You can do that in a professional and politically correct manner in order to respectfully challenge them. If they’ve indicated they have an observation or a notice of violation, take that opportunity to make sure you have presented your case and presented all of your evidence.

Many issues can be resolved during the course of an investigation. If the inspection is concluded and you receive the report and there are observations there that you do not agree with or that you don’t find inaccurate, you can respond in your written response and you can indicate any additional information, artifacts, or rational. You can certainly provide additional information in the response to the Establishment Inspection Report (EIR) but in USDM’s experience, it’s better to resolve any issues while the inspection is still ongoing.  Many times you can resolve issues on the spot so they don’t show in the report as a comment or a 483.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

With Each Submission of Data Using the Cloud System for Integration, Does Each System Need to Be Qualified? If So, How Does That Process Work?

Cloud systems must be qualified. Qualifying a cloud system is similar to the regular qualification and validation of hosting systems. This being the case, there are some nuances within the service that can be helped by selecting the vendor that best suits the needs of your business. The correct vendor can provide stable infrastructure that can be leveraged to qualify your system. Establishing a Service Level Agreement (SLA) with the vendor provides assurance that they will follow the protocol and take ownership of the system’s qualification. To ensure that nothing is adversely affected, vendors provide notice of changes. Changes made are followed by delivery notes as well as risk based testing. When qualifying a cloud system establish a SLA with a vendor that has a stable, reliable process.
The USDM Life Sciences Cloud Team is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.

What is FDA Doing to Enforce the Regulation on Medical Device Manufacturers? What are the Consequences of Non-Compliance for the Provider?

Food and Drug Administration (FDA) is working very closely with all of the manufacturers so there should be few problems with compliance. Some of the manufacturers have requested extensions of 30, 60, or 90 days for various reasons but not for extended time frames. All class III packages should now be received with Unique Device Identification (UDI).

Devices within the supply chain before September 24, 2014 are not required to be re-labeled. There are also exemptions from UDI for kit and non-sterile devices, as well as individually requested exemptions by companies. An assessment of devices that should be in the Global Unique Device Identification Database (GUDID) versus how many are in GUDID will result in a percent compliance. When assessing the need to be compliant for the goods in commercial distribution with the exceptions, there is adequate explanation for why there are less than the expected amounts of devices on GUDID. After taking this into account, report any issues to the FDA so that the FDA is aware of which manufacturers they need to work with for compliance.

With regards to the provider, at this time the FDA does not have a plan to reach out to providers and investigate why the information was not provided. Jean Sargent, Vice President of Healthcare Strategy and Implementation at USDM Life Sciences, has reason to believe that this could change with time. As a case in point, 15 years ago an FDA regulation stated that hospitals could no longer make their own medical devices then sterilize them unless they registered as a manufacturer with the FDA. The FDA began  going into hospitals in order to make sure either all “manufacturing” was ceased or that the organization was approved by the FDA to manufacture products. In this case, FDA worked closely with The Joint Commission using Joint Commission’s surveyors to investigate the compliance. Jean assumes something like this could happen in relation to the current regulation.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

If a CRO is Managing My Clinical Trial Data, What are My Validation Responsibilities?

If you have a Contract Research Organization (CRO) that is managing and hosting your content and you're accessing their content management solution. The responsibility is on the CRO to have a validated compliance content management solution for your content. However, you have to do due diligence and close your vendor auditing practices, as well as your vendor management processes, and your SLA with your CRO to ensure that you've done proper due diligence to make sure that they are properly managing your content. The burden is effectively on the CRO, however you have to do your due diligence to ensure that you're auditing them appropriately out of their system validation materials, as well as making sure that the processes and procedures are up to par for managing content.

The USDM Life Sciences Clinical Services and Solutions team provides our clients (from start-up Biotech to large Pharma/Device) with the latest technology, processes and strategies to assist with efficiency, quality and compliance in any scenario and offers our clients a cost-effective, proactive and unified partnership in goal achievement.

What are the Costs, Elements, and Approximate Timeline to Implement a Compliant Field Service Solution?

It really depends on how many users you're looking at and some of the complexities with your environment and requirements. As far as line items, you're going to be looking at the field service application licensing. We have to get the application into our environment -- into the user's hands. How many people do we have? That is going to be one dollar amount.

Then you've got the implementation services. Those, you can imagine, vary quite a bit depending on, again, the size of your service organization and some of the various requirements that you have with your different field service processes. Those implementation services are also going to include the initial validation that we would perform. Again, it's all one professional service number. Then, you've got the subscription for the ongoing validation documentation that USDM provides with each seasonal release. Those are the ways we would just provide a high level breakout for the different costs involved.

As far as the timeline, what we're seeing out there is an average of 3 to 6 months to implement a validated field service application. Again, the timelines can go up or down based on a couple of things. Most often it's around data migration. How much data are we starting with? Do you have years and years of field service history that we need to bring in and make that available within ServiceMax. If yes, that's just going to take a little bit more time.

Also integration. ServiceMax is built on a platform which is extremely open, and it's not hard to tie in to other systems like your ERP, a complaint management system. But, it's just those things need to be thought about and brought into the project. You can, like I said, depending on the complexity, either lower that amount of time or extend it out a little bit.

The USDM Life Sciences Cloud Team is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.

What is the Recommended Approach for Control on Non-Regulated Laboratory Instrumentation?

Michael Ambrose, Vice President of Lab Services and Solutions at USDM Life Sciences says his approach would be for a calibration or a qualification. For instance, if it's a basic instrument, he’d still want to calibrate it. He would still want to have a set of requirements to say what the calibrations test points and ranges should be and make sure that that system is producing data that I could consider valid, even if it's not going into a regulatory document or submission. The same with qualification. He would definitely have manufacturer's specifications being met before I installed an instrument and the analogy I use often is a librarian is going to want to get their books back if they're using a software to track it. They're going to want to do some type of testing, make sure the software works, make sure it's installed properly and that would go for any of the basic laboratory equipment. The place he would maybe change if it wasn't validated, if it wasn't regulated, would be a validated system.

Ambrose says he might not do the extent of extra documentation, but would certainly have requirements and testing around any software that was used in a lab just for data integrity and data security reasons.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.

Unique Device Identification - A Hot Topic in Healthcare

Unique Device Identification (UDI) took center stage at this year’s AHRMM 15 Conference.  In the hallways and in sessions, including my panel session on the topic, hospitals, regulators, solution providers and suppliers discussed the obvious benefits of having consistent, accurate and unique identifiers for devices and pharmaceuticals to ensure better tracking throughout the healthcare supply chain to reduce counterfeiting, speed recalls and improve post-market surveillance. With the UDI regulation for devices, FDA’s implementation of the Drug Supply Chain Security Act (DSCSA ) and The Joint Commission tissue tracking all in full force this year, in addition to unique ID data capture requirements proposed under Meaningful Use (MU) Stage 3, many hospitals and suppliers are working hard to not only comply, but excel in this incredible time of technology and change. The industry is in the midst of transformation as it learns to harness and hone tremendous amounts of data to propel accuracy, safety and security in the nation’s healthcare system, while also meeting tight regulatory deadlines.

Those who incorporated the UDI into their information systems for last year’s Class 3 implant requirements are reaping the benefits of accurate, consistent product information.  Others still have to catch up. AHRMM attendees stated, for example, that they are not aware of all the UDI requirements, even the ones providers are responsible for, such as storage of the entire UDI, including production identifiers, for retrieval in adverse event reporting.  Proposed MU Stage 3 requirements for Electronic Health Records will provide the software enhancements to make this possible for implanted devices as well as document in registries and support value analysis.  The industry as a whole needs to be better informed on what's in the UDI regulation, who and which items are affected and when the deadlines are.  USDM Life Sciences will publish more details around this topic, including upcoming blogs about which products require UDI and how hospitals can use Master Data Management as a strategy to make sense of all their data.  In the meantime, you are not in this alone.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

Top 10 Key Audit Failures

1. No annual review of Environmental Monitoring data and assessment of the continued appropriateness of current action and alert limits.
2. Environmental monitoring programs which do not establish investigations or actions for a number of alert limit excursions which occur during a discrete time period.
3. Supplier qualification processes which are based criticality of supplier on annual procurement $ spend rather than GxP criticality dimensions such as safety, quality, identity, purity or potency.
4. Supplier qualification processes which allow too long a time period between initial qualification audits and subsequent re-qualification audits.
5. Supplier qualification processes which do not take into account supplier performance history and the need for adjustments to defined audit frequencies.
6. Process qualification of critical quality attribute ranges which are not scientifically justified based upon DOE or other science based rationale.
7. Computer systems validation of key systems used to support quality or production systems which does not include a periodic review process following initial validation to evaluate the collective impact of change controls and the maintenance of the validated state of control.
8. Recall procedures which do not include provisions for a mock recall to verify lot genealogy/traceability.
9. IT back-up processes which utilize automated tools/utilities with no manual review of backup logs to verify that there were no failures or files skipped.  No process for investigation or escalation of backup failures to IT management.
10. Failure of cleaning validation to consider limit of detection, limit of quantification, various materials of construction and risk parameters such as worst-case model compound, solubility, number of difficult to clean areas and total product contact area.  

About the Author:
Robert (Bob) Lesnefsky is the Global Vice President of Quality Assurance and Regulatory Compliance and Auditing at USDM Life Sciences.  He is a seasoned quality assurance and regulatory compliance professional with 30+ years of experience in quality assurance and regulatory compliance in the pharmaceutical, biotechnology, medical device, nuclear and petrochemical industries.  Bob is sought out as the GMP/DEA compliance expert in providing compliance opinions and interpretations of cGMP to manufacturing, operations, quality and client services to ensure compliant drug product manufacturing operations.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

What Would Happen if You Change Your Barcode Standard?

USDM Life Sciences has quite a bit of experience with this. Let’s say you chose to move to GS1 standards, you're effectively changing the label.  You would have to sunset, retire, and create a new record associated with the GS1 standard as your device identifier.

There are some ways to do this that are a bit more flex, if you haven't already submitted the record, that we've helped some clients with. So if you've already submitted, then you're going to have to end date and then create a new record. If you haven't submitted, then take advantage of the primary and secondary DIs that are associated with the product so that you don't have to create new records downstream.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

How are Healthcare Providers Managing their Pharmaceutical Data?

Generally, the information that's coming from the distributor is very well-managed by the distributor through to the hospitals, but using a solution is still a benefit. Where providers have more difficulty with keeping up with the documentation is for their orders that go direct to the smaller companies. That's where the magnitude comes up, but it's probably an 80/20. They order most of their product through a distributor, so it's covered, but they can order from up to 50 smaller manufacturers. They have to have a process in place with each individual manufacturer, and that is very cumbersome.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

What are Healthcare Providers Doing to Implement DSCSA Requirements?

Healthcare providers approach to implementing the Drug Supply Chain Security Act (DSCSA) varies. Some providers have teamed up with a solution provider that helps them to track pharmaceutical information. Others are using manual processes and keeping paper copies of the information. It really varies by organization. However, a paper process in any manner is not sustainable. It's a start. It helps to build the process. It will help the provider to understand the complexity and how having a solution is really going to help them to manage this data much better than a paper process.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

If Not Using the Kit Exception, Does the Kit Itself Need a UDI?

The kit exception doesn't work in reverse. So what the kit exception says is that if you have a UDI on the kit (assuming that it's a kit that meets the intent of the UDI Rule and the regulatory definition that's there now) then the device components are exempt from having to have a UDI on them. And we probably should use the term "component". The devices within the kit do not need to have a UDI on them.

The collection of medical devices, or the kit, in this case, is still a medical device and subject to UDI. So even if each of the devices within the kit have their own UDI, the kit itself is still a medical device and still needs its own UDI that identifies the kit itself. So it doesn't work in reverse.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Will There be More Changes in the Expectations for Reporting Adverse Events Based on the Implementation of UDI?

Jean Sargent, Vice President of Healthcare Strategy and Implementation at USDM Life Sciences says adverse events reporting will become more and more imperative for all of the healthcare providers, as well as the medical device manufacturers. The FDA doesn't regulate the hospitals, so they can take it to a certain point. I'll liken it back to 2000. In 2000, being on the central service side, I was very involved when the FDA said "You can no longer manufacture your own product."

The FDA actually did start going into hospitals and making sure that the hospitals were not manufacturing their own product. There's going to be some way that the FDA is going to work with hospitals, to make sure they are capturing this information and therefore, reporting this information.

Now whether they end up using the joint commission or they end up using Medicare that demands having that UDI information for reimbursement - there will be methods that will be coming up down the road that will drive the adoption and implementation of the UDI within the hospitals.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

Do All Justifications for Direct Marking on Implants Have to be Submitted to the FDA or Can They be Documented in a Device History File for Inspection by the FDA?

The UDI Rule says that you need to have a permanent UDI on the device itself.

Direct Part Marking (DPM), is a set of technologies that are used both in medical device space, and widely in the DoD space, to apply typically bar codes to often metal or hard surfaces. One of the technologies to apply barcodes to surfaces is laser etching. There’s a number of different technologies that are out there.

But direct part marking is one way to meet the direct mark requirement. Obviously, there are permanent labels, tags, other ways as well, and some of this is discussed as well in the FDA's guidance on the topic.

On the issue of exceptions built into the Rule, I didn't touch on them today, but just like the single-use vice packaging and convenience kit exception, integral to the UDI Rule are a number of direct marking exceptions. They are listed there. And just like the single-use device packaging exception or the convenience kit exception, these exceptions are noted in the DHF of the particular device. So if you decide, for example, that it is not technologically feasible to directly mark your device, this is something you note yourself. All of these exceptions are things, all the exceptions that are integral to the Rule are things that you note yourself and do not have to request from the FDA.

There is an exception and alternative process that is built into the Rule, so if for some reason you believe you can't meet the Rule as we just talked about it and the exceptions that are integral to it are not sufficient, you can request from FDA a specific exception alternative. We've done a number of those for clients. There's some more information on FDA's website. If you have questions about it, please let us know.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Is UDI’s Assumed Application to Class III Medical Devices Connected with Serialization Initiatives?

At this point, there are no serialization or track and trace mandates in the United States that apply to medical devices. There are a number of activities in the pharmaceutical space for drug track and trace, specifically FDA’s Drug Supply Chain Security Act (DSCSA) legislation that requires eventual serialization of pharmaceutical products. There is nothing like this in the realm of medical devices.

Currently, UDI is solely concerned with medical device identification and its associated metadata. All stakeholders throughout the life cycle of the device should utilize UDI, but there is no mandate to either serialize or manage the traceability of the device the way there is within the pharmaceutical space.  If, in the future, serialization initiatives move into the medical device space, UDI could support this.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

How Does the UDI Rule Address Subcomponents or Accessories in Regards to the Statement that Every Medical Device Needs UDI?

Although the words “accessory” and “component” are often used as generic terms when discussing devices, they each have regulatory definitions. From a regulatory perspective, “accessories” are specific objects that work with finished medical devices and are therefore regulated devices in their own right and subject to UDI. “Components” are defined as objects that manufacturers acquire or build and then use to create medical devices. These are not put into commercial distribution. Therefore, UDI does not apply to components. UDI applies to finished medical devices and accessories that are put into commercial distribution, sold, and distributed.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

UDI is Paradigm Shift for Healthcare

It is a new year and the healthcare world is ever evolving. The UDI Rule is in progress with manufacturers working to comply including submitting information to the GUDID. Meaningful Use Stage 3 was presented in October indicating the EHR software is to be capable of accepting the UDI. Use of the UDI within the healthcare provider is gaining adoption through means of software providers, clinicians, supply chain and information technology. The metadata associated with the use of the UDI is becoming more apparent and open for discussion on how to best manage and utilize the information.

The metadata will be collected from multiple systems across an organization using key terms to synchronize the data and generate meaningful reports in regards to purchase history, recalls, patient outcomes and reimbursement.

All that we do in regards to use of the UDI is patient safety focused. The paradigm shift requires implementation of a strategy by segment bringing together the stakeholders, discussing the influences, testing and proving the concept is possible to implement.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

Is it Possible to Add Additional Product Data to What is Available Via the GUDID?

Yes, after getting UDI Connect into your Salesforce Org, go to the AppExchange and bring down the desired package. Once this happens, it is possible to add any field, pick lists, and look-ups from the Global UDI Database (GUDID) to the app. The app is highly customizable as USDM does not limiting like other managed packages. The application is flexible and designed in this way because USDM understands that all clients have different processes and practices as well as different intended uses for the application.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Do Systems Need to be Updated in Order to Handle New Quantities and What Best Practices Does USDM Believe Will Emerge?

Jean Sargent, Vice President of Healthcare Strategy and Implementation at USDM Life Sciences, has been speaking with numerous solutions providers in order to understand where they are in relation to capabilities to transact with the UDI data. From the perspective of the supply chain, most of the large supply chain solution providers already have the capabilities to handle the capabilities built into their systems. If this capability is not on a built in version, solution providers have determined a path that allows the utilization of this information using subfields. When there is an upgrade all of the information will be in the correct fields and this information can then be used for transactions.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

Is an Immediate Wave of Product Labeling Changes from all Manufacturers Expected?

It has been over a year since the Food and Drug Administration (FDA) required that class III devices were to be labeled with Unique Device Identification (UDI). Despite the common sentiment that labeling regulation can cause a great deal of reorganization and work, the packaging label is valuable. If you already have a packaging string built into your Item Master, you simply associate each UDI with that packaging string. The UDI for a 4by4 will have a different number for the package, box, and case. Use of this information within the Item Master ensures orders will transact utilizing the correct UDI with the associated product.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.