Friday, August 26, 2016

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.

Thursday, August 18, 2016

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.

Tuesday, August 9, 2016

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.  

Monday, August 8, 2016

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.

Friday, July 29, 2016

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.

Tuesday, July 19, 2016

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.

Monday, July 11, 2016

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.