Special Section “FDA 21 CFR Part11 & European GMP Annex 11-Electronic Records and Electronic Signatures”
Part 11 Issues for Quality Control Laboratories
2002 Volume 4 Issue 1 Pages 52-55
Details
2002 Volume 4 Issue 1 Pages 52-55
Requirements regarding electronic records and signatures were published in the United States Federal Register 21 CFR Part 11 in August 1997. These requirements regulate the control of records and signatures and associated security issues in order to respond to the movement towards paperless systems. In the QC lab, printouts from analytical equipment are often treated as raw data and especially for analytical equipment which are computer controlled, where the output is received via electronic media, compliance with the requirements of 21 CFR Part 11 is required to assure the output results. Taking QC lab circumstances into account and aiming towards compliance with 21 CFR Part 11, the preparations and planning, items for investigation and audit preparations are considered.
