How Apex Can Help
Apex's computer system validation and 21 CFR Part 11 services formally incorporate a business process-driven, risk-based approach to compliance as an integral part of the SLC to ensure compliance with regulatory requirements. Apex consultants have expertise in regulatory requirements, CSV methodologies, the technical aspects of computer system development, and the surrounding business processes. The team's comprehensive knowledge and experience are essential for effective and efficient scaling and execution of CSV activities. Our senior consultants are experts in managing and coaching developers, users, and validation teams to ensure successful conclusion of system implementation and validation efforts.

Apex's CSV services cover the full system life cycle, from requirements analysis through system retirement, and are fully integrated with complementary business and regulatory compliance services.

21 CFR Part 11
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 Subsequently, the agency released a Compliance Policy Guide and several draft guidance documents. Over the years, the industries and life science organizations impacted by Part 11 expressed numerous concerns regarding the interpretation and implementation of Part 11. During the same time period, FDA introduced its initiative to develop a science and risk-based approach to pharmaceutical current Good Manufacturing Practices (cGMPs).

Responding to these concerns and reflecting its own risk-based initiative, FDA withdrew the Compliance Policy Guide and draft guidance documents, released a final guidance on the Scope and Application of Part 11, and updated its final guidance on the Use of Computerized Systems in Clinical Trials. In 2004, FDA committed to reevaluating and eventually publishing a proposed rule amending Part 11. All of 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 Apex Can Help
In implementing regulatory solutions in line with FDA's initiative to develop a science and risk-based approach to pharmaceutical cGMPs, Apex assists and guides you in adopting an enterprise-wide view of systems and their supporting processes. We also help you determine where and how they fit in the overall drug process and the potential effect on product quality and patient safety of a failure in any part of this process.

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.

In essence, Apex works with you to take the FDA's 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.