Wednesday, December 28, 2016

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.

Friday, December 23, 2016

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.

Wednesday, December 21, 2016

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.

Monday, December 19, 2016

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.

Thursday, December 15, 2016

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.

Monday, December 12, 2016

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.

Thursday, December 1, 2016

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.