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.Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) are key inputs into user requirements specifications which are required to support the Quality Risk Management based Commissioning and Qualification process and are identified prior to User Requirement Specification generation. ![]() Brief highlights of answers to FAQs from prior workshops include: The User Requirements Specification document contains requirements from multidisciplinary sources and supports design, commissioning and qualification activities, operations, and maintenance. Design Review/Design Qualification, moderated by Nathan Temple, CAI Periodic Review, moderated by Alex Mendoza, Takeda.IT/GAMP® 5, moderated by Steve Wisniewski CAI and Verification (commissioning and qualification execution), moderated by Zachary Luce, Project Farma.Quality Unit, moderated by Nick Haycocks, Amgen System Risk Assessment, moderated by Steve Wisniewski, CAI.User Requirements Specifications (URS), moderated by Stephanie White, Amgen.The four key focus areas covered in this blog series will be: The townhall will be moderated by the panel of authors with each panelist reviewing and answering your questions on these key areas. ![]() The posts will be followed by a live townhall session, scheduled for Tuesday, 7 July 2020. Over the coming weeks, each blog post will cover four key focus areas discussed in the guide. The guide provides a well-defined framework for a lifecycle Quality Risk Management (QRM) commissioning and qualification (C&Q) approach to verification and documentation of fitness for use. This blog is the first of four posts addressing questions received during the August 2019 webinar summarizing the introduction of 2nd Edition, ISPE Baseline Guide Vol 5: Commissioning and Qualification.
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