What is the issue?

21 CFR Part 11 became law on 20 August 1997. The regulation outlines its criteria for acceptance of electronic records, electronic signatures, and handwritten signatures. It allows electronic records to be considered equivalent to paper records and handwritten signatures. The rule applies to all industry segments regulated by FDA and includes cGMP, GLP and GCP.

How will it affect you?

21 CFR Part 11 has important implications for any company using a computer for cGMP, GLP and GCP. The FDA expects affected companies to either be in compliance with Part 11 or to be executing a well-established plan within the company towards becoming fully compliant. You and your company have the responsibility to develop strategies to identify, re-mediate and validate non-compliant systems, as well as creating standards for new systems. 

What can we do for you?

A4 Computers have the knowledge and expertise to help your company in its effort to develop a well-established plan and to proceed to implement and validate that plan to bring your company into compliance with 21 CFR Part 11.