The US FDA, during the middle of 2002, launched its initiative to develop a science and risk-based approach to pharmaceutical cGMPs, issuing a final report on this initiative two years later. A risk-based approach uses a systematic approach to processes, systems, infrastructure, organization, and documentation that leverages recognition by regulatory authorities that noncompliance gaps may vary widely in levels of risk and importance. In the fall of 2003, six years after 21 CFR Part 11 (Electronic Records; Electronic Signatures) went into effect, the FDA issued the much anticipated final guidance on the Scope and Application of Part 11. The FDA advises the industry, in the cGMP initiative and through subsequent guidance documents, 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.
Using a risk-based approach requires careful thought, analysis, understanding, and documentation. The life sciences industry is now taking a risk-based approach to regulatory compliance and making it a strategic initiative. For more information see the US FDA links at www.fda.gov/oc/guidance/gmp.html
www.fda.gov/bbs/topics/news/2004/NEW01120.html .
How AQS Can Help
AQS' consultants use a risk-based approach that involves compliance readiness evaluations, establishing context and scope, discovering gaps and analyzing risks, identifying mitigation solutions, and preparing an implementation plan. This process combines people, processes, and technology and spans the system life cycle. AQS' methodology can be customized 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 tracking and monitoring.
AQS will assist you in formally incorporating a business process-driven, risk-based approach to compliance which will help reduce unanticipated hazards and business interruptions, prioritize risk initiatives to more effectively and efficiently allocate resources to remediation (bring into compliance) and compliance related activities, as well as focus resources on areas critical to growth and profitability, including investment in new technologies. You have the opportunity to reevaluate, improve, and optimize SLC and CSV methodologies and thus produce better systems more effectively and more efficiently.
AQS' Expertise
- Regulatory Risk Assessment
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- System Compliance Strategy
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- Execution of Technical and Procedural Remediation Activities
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