BASICS OF 21 CFR PART 11 COMPLIANCE
Life science, biotech, pharmaceutical, and medical device companies are heavily regulated, and therefore the framework for the right management of digital records that would be submitted electronically during a regulatory FDA filing is 21 CFR Part 11, paralleled by Annex 11 within the EU. As automation supported by sophisticated vision systems has become essential to the manufacturing of medicine and devices, Part 11 has become a subject of concern for quality managers worried that their processes might not be compliant. Fortunately, ensuring compliance is easier and more straightforward than generally realized, supports all other compliance requirements, and provides for best practice record-keeping procedures generally . Any manufacturer with an automatic quality management system (QMS) that's Part 11 compliant will find that it generally enhances operations. All that's required may be a little bit of extra attention to the precise requirements of mach...