For life science companies, 21 CFR Part 11 compliance has always been a challenge. While using a cloud-based quality management system helps streamline compliance processes by allowing for digital signatures, organizations must be sure to tick all the boxes when it comes to complying with stringent FDA guidelines.
21 CFR Part 11 is an FDA guidance that sets out how organizations operating in the United States can use electronic records and digital signatures in their quality management systems to replace paper-based documents and “wet signatures”. Put simply, any organization that uses quality management and needs to conform to FDA regulations, such as pharmaceutical and life sciences organizations, should be aware of 21 CFR Part 11 and its requirements.
WCCS empowers small to mid size companies with fractional and on demand compliance consulting and expertise.