Each organization is now tasked with updating their annual compliance training that incorporates Traceability. This involves not only good documentation practices, but transcends every aspect of the quality system to include areas such as data governance. Integrally important to traceability is a comprehensive assessment of compliance with CFR 21 Part 11 and how an organization is managing its repository for e-signatures, short and long term records archival as well as paper hard copy documentation.
PQE Group has demonstrated operational excellence in this area by helping companies on a global basis to realize the benefits of harmonizing and standardizing their processes to adhere to regulatory guidelines while following industry best practices.
Examples of questions an organization should ask about traceability include:
- When was it transferred?
- How was it stored?
- Where are the storage facilities?
- Why was this returned?
- Who was the person that signed for the product?
- Which pallet is in question of the lot that was damaged?
As organizations consider their forward and reverse supply chain processes and systems used to support business operations, it is imperative that they are able to answer all questions regarding traceability as part of new serialization requirements set forth over the past several years.
PQE Group can support your needs, educate your personnel, and ensure compliance for your product development and manufacturing. Call us to discuss ALCOA++ and how we can help your business.