- Can we validate the multi-tenant cloud?
- What is your technology expertise?
- What internal resources do you require for the audit?
- Can a cloud technology provider qualify as a life sciences vendor?
- Do you offer Compliance Gap Analysis Audit as a stand alone service?
- What EPCIS version should we use?
- What is GTIN?
- What are the risks if we can't meet the serialization deadline?
- Do I need to serialize inner-pack?
- Does the case 2D data matrix contain the data of all the serial numbers in the case?
- Do I need to aggregate?
Can we validate the multi-tenant cloud?
Life sciences companies can not validate multi-tenant cloud alone. Your vendor is responsible for IQ, and you for PQ. OQ can be a combination of vendor or in-house efforts. Since cloud structures are vastly different from one vendor to the other, we like to understand more of you particular set up so that we can help you sort out the difficulties. Please email firstname.lastname@example.org or call us at (248) 973 2008.
What is your technology expertise?
Our colleagues have worked in extended capacity of various technology products as developers, users, implementors, architects, integrators, marketers, and strategic decision makers. The technologies we specialize in are:
What internal resources do you require for the audit?
Our primary contact is QA. If you don't have a dedicated QA personnel, we work with various functional groups including HR, Purchasing, IT, R&D, Manufacturing, etc. to conduct reviews and make recommendations.
Can a cloud technology provider qualify as a life sciences vendor?
We have proven track record helping cloud technology providers to become qualified life sciences vendors. Our 3 step compliance service is designed to help technology companies and their cloud products to meet the requirement of their life sciences customers.
Do you offer Compliance Gap Analysis Audit as a stand alone service?
Compliance Gap Analysis is the first step of the 3-step-compliance service followed by Remediation & Final Audit. Compliance Gap Analysis Audit can be commissioned as a stand alone service independent of who will be responsible for remediation or final audit.
What EPCIS version should we use?
There are 3 EPCIS versions: 1.0, 1.1, and 1.2. EPICS 1.2, published in September 2016 is the latest. In addition to the serialized product's event data, it also contains Transaction Information and Transaction Statement that are required by the DSCSA. When exchange data with trading partners involving products changing ownership, EPCIS 1.2 should be used. Otherwise, 1.0 and 1.1 are fine. Here are some examples:
- A manufacturer receives the packaging data from a CMO. In the case, EPCIS 1.0, 1,1, and 1.2 are all fine.
- A manufacturer sends serial shipment data to its wholesale distributor customers. In this case, EPCIS 1.2 should be used for the reasons that it contains TI and TS.
What is GTIN?
GTIN stands for Global Trade Item Number. The combination of GTIN and the serial number makes an Rx unit unique in the global supply chain.
What are the risks if we can't meet the serialization deadline?
All Rx drug products are required to be serialized before the November 2017 deadline. Unless you are exempt, grandfathered, waived, or granted exceptions by the FDA, or the FDA delays the enforcement, drug products without serialization are considered illegal in the United States after November 2017.
Do I need to serialize inner-pack?
The DSCSA requires serialized product identifier on the smallest saleable units and their cases. The DSCSA does not require the inner-pack to be serialized. However when wholesale distributors ship the inner-packs, they don't cut the packs open. Without a serialized label on the inner-pack, it's difficult for wholesalers to capture the individual unit serial numbers in the pack.
Does the case 2D data matrix contain the data of all the serial numbers in the case?
No. When you scan the case 2D matrix, you will get one serial number - the serial number of the case. The case 2D matrix does not contain the data for all the serial numbers in the case.
Do I need to aggregate?
The DSCSA does not require aggregation. However, wholesale distributors see aggregation as a necessity when they ship pallets, cases, and bundles. Without it, the wholesales distributors don't know what serial numbers are in the pallets, cases, and bundles.