21 CFR Part 11 requires Food and Drug Administration (FDA)-regulated industries, including medical device manufacturers, drug makers, biotech companies and biologics developers, to have validation documentation and implement controls such as audit trails and electronic signatures. Implementing a chromatography data system (CDS) that provides all of the necessary functionality built-in to one package can significantly reduce the effort required to achieve compliance with 21 CFR Part 11.
In this white paper we discuss:
- What procedural and administrative controls are needed for compliance to 21 CFR Part 11
- Which requirements apply to software and systems involved in processing electronic data to demonstrate compliance with FDA predicate rules
- How Thermo Scientific Chromeleon CDS facilitates compliances to 21 CFR Part 11