In mid-2002, US FDA launched its initiative to develop a science and risk-based approach to pharmaceutical cGMPs issuing a final report on this initiative two years later. In the fall of 2003, six years after 21 CFR Part 11 (Electronic Records; Electronic Signatures) went into effect, FDA issued the much anticipated final guidance on the Scope and Application of Part 11. In the cGMP initiative and through subsequent guidance documents, FDA advises the industry to take a risk-based approach to compliance by focusing compliance efforts on areas that are the most likely to impact patient safety, product quality, and record (data) integrity.
The 21 CFR Part 11 Scope and Application guidance in particular provides the framework for industry to adjust compliance methodologies, Part 11 remediation strategies, and computer system validation approaches in order to incorporate risk-based compliance management. With varying degrees of success, system developers and implementers have long been trying to take a practical (a.k.a. risk-based) approach to computer system validation. More recently, industry has begun addressing 21 CFR Part 11 implementation as part of a broader risk-based approach to compliance.
A risk-based approach highlights the importance of viewing compliance not as an initiative executed in a vacuum, but one that requires careful thought, analysis, understanding, and documentation. As a result, taking a risk-based approach to regulatory compliance has now become a strategic initiative for the life science industry.
How Patni Can Help
Patni's risk-based approach is a holistic one that combines people, processes, and technology. Patni's methodology can be integrated into your own risk-based approach or be customized or fine-tuned to adapt to your specific environment. Regardless of the degree of integration or customization, this risk-based approach helps you identify, assess, and manage risk, while ensuring consistency and completeness, documentation and auditability, review and approval, prioritization and investment, and tracking and monitoring.
Patni assists you in formally incorporating a business process-driven, risk-based approach to compliance as an integral part of the system life cycle (SLC) and computer system validation (CSV) effort, helping you ensure compliance with predicate rules and providing a mechanism for your users to be more actively engaged in the initiation of and throughout the SLC and CSV processes. You have the opportunity to reevaluate, improve, and optimize SLC and CSV methodologies and thus produce better systems more effectively and more efficiently. Such an approach will also help you shift compliance from a system-specific or business unit focus to part of an enterprise-wide, strategic initiative and focus your efforts on those areas and activities where the greatest value will be realized.
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