The FDA published 21 CFR Part 11 in 1997. It had a wide variety of consequences that impacted the use of electronic systems in the pharmaceutical industry. In the area of raw electronic data, due to the heterogeneous nature of the systems deployed, implementation of the law in the pharmaceutical industry nevertheless continues to be very patchy.
This only changed when the Guidance for Industry - Data Integrity and Compliance with CGMP was issued. The FDA has made it unmistakably clear that device data must meet the requirements of 21 CFR Part 11. Printouts of data (at least in the case of complex systems, e.g. HPLC) will no longer be acceptable. In previous years there have already been various warning letters dealing with the issue of how to handle raw electronic data.
We subsequently flag up the various requirements which 21 CFR Part 11-compliant raw data archiving must satisfy. By demonstrating our BM-windream system, we show an elegant way of mastering these challenges with ease.
Take this opportunity to get a quick overview of the system by signing up for our free-of-charge webinar on October 13!
Thorsten Dunker,
Founder and Managing Director of BioMedion.
Implementation of raw data management projects since 2001.
Invited speaker to various subject matter events on the topic of raw data management.
- 21 CFR Part 11 – application of raw data (records management)
- Electronic archiving (long-term)
- Long-term stable file formats
- Vendor independent solution
- Heads of Research and Development
- Heads of QA
- Heads of IT
