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.