21 CFR Part 11 is an FDA regulation that outlines the criteria for acceptance of electronic records and electronic signatures. Effective since August 20, 1997, the regulation applies to all industry segments regulated by the FDA, including cGMPs, GLPs and GCPs. Invensys offers tools, technologies and services that specifically address 21 CFR Part 11 .
The Invensys “21 CFR Part 11 Ready” logo emphasizes the fact that compliance requires validation and not just technologies alone.
21 CFR Part 11 Consulting and Expertise
One of our core competencies is automation and systems validation and consulting services. Our staff of experts — senior validation consultants, engineers, and project managers — provides in-depth knowledge and experience in key areas. These services are based on our expertise and understanding of laboratory, research and development, clinical, quality systems, production and information technology or business systems processes. This know-how extends to primary and secondary manufacturing and business facilities.
We partner with our customers to provide a combination of policies, procedures, security, and automation tools to comply with 21 CFR Part 11. We can assist you with procedures and policies that need to be put in place to use or implement the system’s electronic records, audit trails and electronic security capabilities. We also offer procedural guidance and recommendations to our pharmaceutical clients to assist them in complying with the relevant portions of 21 CFR Part 11.
“The Invensys team helped us develop and execute a comprehensive site Validation Master Plan including close monitoring and guidance during the pre-inspection activities. From start to finish, we were able to rely on knowledgeable and customer-focused Invensys personnel to help us achieve excellence in computerized systems validation and 21 CFR Part 11 compliance.”
Bill Gilbert
Director Business Development
Draxis Pharmaceutical
