Analyst LC/MS Software & 21 CFR Part 11.

The article offers information on the United States Food and Drug Administration's 21 CFR Part 11 regulation covering the trustworthiness and reliability of electronic records and electronic signatures. An important driver for the regulation was the pharmaceutical industry. A summary of significant requirements of the 21 CFR Part 11 regulation are outlined. The impact of the Part 11 scope and applicability guidance on bioanalytic laboratories are also highlighted. The regulation also defines open and closed systems. Roles and responsibilities involved in the regulation, as well as its benefits are described.