21 CFR Part 11

Introduced in 1997, the US FDA issued 21 CFR Part 11 (Part 11) – the regulations that govern electronic records and electronic signatures. Subsequently, the agency released a Compliance Policy Guide and several draft guidance documents. These changes have resulted in some degree of uncertainty regarding the future of Part 11. However, balancing regulatory compliance and business objectives remains a paramount goal of the industry as a whole.

How AQS Can Help

AQS assists and guides you in adopting an enterprise-wide view of systems and their supporting processes. Our approach encourages the regulated industries to make informed decisions that are more objective, better documented, and carefully quantified across both processes and systems. The success of this approach can be ensured by using the appropriate combination of methodology, tools, skilled resources, processes, and documentation.

AQS works with you to take a risk-based approach to Part 11 and transform it from a mechanical and tactical exercise into an ongoing, strategic one that requires analytic thinking and experience-based decisions that can ultimately reduce compliance costs, add business value, and ensure safety.

AQS' Expertise
  • Compliance Plan Development
  • System Compliance Strategy
  • Remediation Planning
  • Execution of Technical and Procedural Remediation Activities
  • System Assessments
  • Awareness Training
  • 21 CFR Part 11 Interpretation
  • Regulatory Risk Assessment
  • Advanced Training