In 1997, the United States Food and Drug Administration (FDA) overhauled its GMP, or Good Manufacturing Processes. Out of the ashes came 21 CFR Part 11, a regulation that places certain demands on drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries regarding their use of technology—specifically, defining the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
Accuracy and accountability are extremely important with the use of such records, and this strategic initiative is aimed as ensuring that both are upheld in both manufacturing and product quality. The main issues that Part 11 addresses are audibility and the validation of electronic signatures, and it governs much of how pharmaceutical companies document their processes and procedures from research to marketing. Any small business that intends to sell into the pharmaceutical market—through conducting research studies, for example—will fall under the regulatory standard as well.
Luckily, there are employee time tracking software solutions that can help small businesses be Part 11 compliant. The first step is to know what you are looking for. The right solution must exhibit several qualities…
Decipher the designation at:
http://journyx.com/rss/redir/smartbiz-21cfr11.html