White paper: Achieving FDA Regulation 21 CFR Part 11 Compliance

This whitepaper provides information on how automation change management features align with requirements set forth by the FDA. More specifically, it contains guidance related to FDA regulation 21 CFR Part 11 for organizations considering AUVESY-MDT software solutions. The intent is to establish a mutual understanding of the rules set forth in Part 11 and explain how AUVESY-MDT can help our customers comply with the rules.

Programmable Logic Controllers (PLCs) are the backbone of automated manufacturing in the pharmaceutical, biotechnology, and medical device industry. These devices are programmable and rely on digital programs that define their functionality and operation. The programs are stored electronically in the device and on backup electronic media. For this reason they are considered electronic records and fall under the requirements imposed by 21 CFR Part 11. Methods for conventional office records tracking and change control would not be sufficient for records associated with programmable devices. AutoSave is part of the change control and audit infrastructure that ensures regulatory compliance.