Breaking News! FDA to Audit Pharma's Electronic Recordkeeping

We sent our valued clients and colleagues this update last week, but for those of you who are not on our mailing list...

The FDA will begin auditing pharmaceutical companies electronic recordkeeping capabilities to evaluate the industry’s compliance with 21 CFR Part 11.



According the article by Ed Silverman of Pharmalot, “…the FDA is about to begin a series of so-called inspectional findings at many drugmakers… The precise timing and number of facilities to be audited - and these are audits, in effect - has yet to be determined, but they will be conducted by the FDA’s Center for Drug Evaluation and Research, or CDER.”


To view QPharma’s webinar on how to stay Part 11 compliant with your training systems, visit our website here. Simply register on the site to take advantage of the Part 11 recording that, when aired live, attracted over 200 attendees from 7 different countries worldwide. It also contains a high-level overview of iCertify 3.0, QPharma's 21 CFR Part 11 Compliant training system for the life science industry.

For the full article, click here: PharmaLot