![]() ![]() Laboratory instruments are not in the scope of the Guide. Can the Guide approach be applied to lab instruments including any associated automation? GAMP® describes a science and risk based approach, and the GAMP® organization are always looking for ways to optimize the approach. IT and IS are out of the scope of the Guide and fall under GAMP®. What is the impact of the Guide on IT and IS systems, (i.e., ERP, SAP, etc.)? These aligned user requirements are verified using an integrated testing strategy. For automation/Process Control Systems attached to systems and equipment the user requirements specifications for each must align when addressing critical process parameter control, alarm management, and data management. GAMP® describes a science risk-based approach for hardware and software development. All other computerized systems fall under GAMP®. The scope of the BG5 revision is equipment and automated systems. What is the alignment between the new Guide and GAMP® 5? The user requirements specification document should not contain the content of engineering specifications and standards, the means by which user requirements are met, or contain contractual contract requirements.User requirements specifications are living documents that are updated as requirements change during any phase of a project or as additional risk controls are identified.User requirements specifications documents can be written around a platform to address the requirements of a multi-purpose operation. ![]()
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