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.