The Pandemic Has Kept the FDA Out of Many Pharmaceutical Plants.
Of course, with everything else coming to a screeching halt because of the pandemic, so did the in-person FDA inspections of pharmaceutical plants. Because of travel restrictions, either21 CFR Part 11 Compliancy inspections had to be deferred or other means of remotely inspecting these plants had to be employed.
One of the ways was to do a remote inspection of records. Because documents are now kept virtually, this can be done readily.
The FDA has allowed several manufacturing facilities to complete the inspection process remotely.
The importance of digital and producible data has never been greater than during times like these.
VisionVault Makes It Happen.
- This software was designed by Integro Technologies for the Cognex Insight Platform for a medical or pharmaceutical production line.
- One login, in one system.
- Produces a streamlined validation process
- Simply log in with a Radio Frequency Identification (RFID) badge.
- The Database Query tells who logged in, which camera they logged into, when they logged in, what terminal they logged in from, and what changes they made.
- FDA:21 Part 11 compliance database
- Great for user management, user traceability, and data archiving.
Contact us for an engineered solution to your FDA:21 Part 11 compliance database needs.