Best Practices of CSV & 21 CFR Part 11 Compliance

Posted on January 31, 2021May 9, 2021 by admin

The cost of compliant CSV can be as much, if not more than the remaining tasks required for system development and implementation. A balance must be reached in order to achieve compliance while minimizing cost of CSV. There are specific industry best practices for effectively controlling the cost of system validation. The cost of longer-term Read more about Best Practices of CSV & 21 CFR Part 11 Compliance[…]

Data Integrity & 21 CFR Part 11 Compliance Requirements

Posted on January 31, 2021May 10, 2021 by admin

21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using: Electronic records (ER), and electronic signatures (ES). Each title of the CFR addresses a different regulated area: 21 CFR relates to Pharmaceuticals and Medical Devices. Part 11 Read more about Data Integrity & 21 CFR Part 11 Compliance Requirements[…]