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.