Regulatory
Automate the GAMP 5 process. Reduce audit times and findings, and decrease the risk of product recalls. Improve product quality and safety. Increase customer satisfaction and ensure regulatory compliance. QMS software makes it all possible.
Understand the product and processes. This is critical to help determine requirements for a quality management system (QMS) that meets your needs. The right QMS helps make risk-based decisions, which makes it “fit for use.”
GAMP 5 expands on what it means to take a life cycle approach to a computerized system. It now includes all phases and activities. This means everything from concept and implementation through operation and retirement. These should be defined within the QMS.
Scale life cycle activities. GAMP 5 guidelines explain this should happen according to system impact on patient safety. Then system complexity should be taken into account. This should be followed by the outcome of supplier assessment. A quality management system can help.
Science-based quality risk management has numerous advantages. It allows companies to focus on important parts of the computerized system and develop controls to mitigate risk. GAMP 5 describes a five-step process for risk management. The approach is based on ICH guidelines. They recognize that this is not the only method. Each company should decide which approach works best for its intended use.
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In 1991, a group of pharmaceutical experts in the UK started GAMP. They wanted to meet the changing expectations of the FDA for GMP compliance of manufacturing and related systems. Now they are a global organization. GAMP 5 provides “pragmatic guidance, approaches, and tools for the practitioner.” This helps companies find the best approach for validating GxP computerized systems.
GAMP 4 was released in 2001. For seven years, GAMP 4 was used for computerized system validation. Over time, regulatory bodies made significant changes to their approach to regulatory compliance. With those changes, GAMP 5 became necessary. GAMP 5 is designed to be compatible with numerous international standards.
Learn how to meet the requirements of GAMP 5 with the right QMS.
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