By playing an active and coaching role, we provide validated systems that satisfy every aspect of compliance. In short, we offer GAMP 5® consultants with the right experience and skills for short and long-term projects – internal or external.
GAMP 5 GUIDELINES PDF PDF
If you are not sure if your system needs to be validated, we advise you on the best approach and working method. GAMP5 GUIDELINES PDF - The new GAMP-5 guidelines were released February at the ISPE Manufacturing Excellence Conference in Tampa, Florida. We are able to guide your company during validation processes, or completely carry out your project from A to Z, including planning, testing and writing documents like user requirements. Patient safety is affected by the integrity of critical records, data, and decisions, as well as by aspects that affect physical attributes of the product. QbD offers consultants for various kinds of assignments. GAMP 5’s stated aim is to assist in achieving patient safety, product quality, and data integrity, while enabling innovation and technological advances. By correctly interpreting and applying the GAMP 5® guideline, companies working in regulated industries can ensure automated systems quality. Compared to previous versions, the emphasis is more on risk control and quality management.
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Together, we tackle possible gaps to make your quality system more robust and audit-proof. Currently, version 5 of GAMP (GAMP 5 ®) has a definitive status, with no version 6 in the pipeline. We work in the most efficient way possible and we help you focus on product quality and patient safety while reducing validation costs. GAMP5: A Risk-based Approach to Compliant GxP Computerized Systems 4 White Paper Scalable Lifecycle Activities Within the GAMP 5 guidelines GAMP outlines that lifecycle activities should be scaled according to: System impact on patient safety, product quality, and data integrity (Risk Assessment) System complexity and novelty. Our GAMP 5® experienced consultants are up to date on the latest insights (including Data Integrity, outsourced systems, artificial intelligence and machine learning) and make use of a pragmatic, risk-based approach – based on their expertise and industry best practices.