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
Leads a team of professionals with 15 years of experience in successfully implementing raw data management projects.
Trainer at renown European training institutes for raw data management
Speaker at various subject matter events for raw data management
Subject matter expert in Process and Training management
- Understanding FDA requirements in regards to device data archival, a view to practical appplications
- How to avoid FDA warning letters?
- Long term electronic archiving
- Importance of vendor/device agnostic file formats
- Heads of Research and Development
- Heads of Research Lab
- Heads of QA
- Heads of IT
- Research Project Managers
- QC Specialists
- Auditors
- Compliance Managers
- Health Informatics
- IT Application Support
- Heads of Record Management
- Director of Record Management
- Record Manager
