Ready for the New Focus on Data Integrity?
Application Note Feb 08, 2018
The U.S. Food and Drug Administration introduced 21 CFR Part 11 to regulate electronic records and electronic signatures used in several industries, while the European Union’s EudraLex issued Annex 11 to cover computerized systems in pharmaceutical companies producing medicinal products for both human and veterinary use.
This paper outlines the requirements of 21 CFR Part 11 and Annex 11, and provides information on how LabVantage software supports customers in complying with the regulations including:
- how dynamic auditing in LabVantage 8.2 complies with new draft guidance on temporary data
- how this software helps you to comply with Part 11, Annex 11, and the draft guidance on temporary memory