Optimizing Quality Control Electronic Records for 21 CFR Part 11 Compliance

The FDA’s 21 CFR Part 11 guidance on the use of electronic records for data retention or submission is clear. With manually implemented Standard Operating Procedures for Quality Control testing and manual transcription of the test results still common practices in the pharmaceutical QC world, the resultant opportunities for human error raises concerns over the integrity of the data in the final electronic record, no matter how safely the record is stored.

This Webinar describes how Quality Control instruments can be optimised for pharmaceutical use, helping to improve the integrity of the data in electronic records.