11/14/2023 0 Comments Gamp category 3 examples![]() After much debate, the approach agreed upon was to rely on the knowledge and collective experience of the workshop teams to create a baseline for H/M/L assignation and then to consistently apply it to the system. GAMP 5 suggests that a scientific approach to risk assessment be applied. GAMP 5 provided the following error occurrence by transaction: 100 = L 1,000 = M and 10,000 = H. One of the challenges with any risk assessment process is the assignment of H/M/L (high/medium/low) and the dependencies between justifying one risk as higher than any other. As the project progressed, the risk assessment was revisited twice once after the user requirements were defined and again after the business blueprinting or functional specifications were written. Each risk identified was clearly designated as GMP or otherwise. All risk considerations were evaluated and where applicable, remedial actions were identified based on criticality. The risk assessment included key GMP risks and other business risks, including those related to Sarbanes-Oxley (SOX). Train – teach the business how to use the system.Define – create the user, configuration, functional and design specification.The company was able to apply the four themes in the context of their own business model to develop the following: Ensure users are trained on said configuration. Ensure configuration is managed post-go live andĤ. Ensure configuration is adequately tested ģ. Ultimately, the following four themes repeated themselves as potential remedial actions were developed:Ģ. ![]() Representation at the workshops included manufacturing, production planning, quality assurance, quality control, distribution, sales, customer service, IT, and validation. Risk assessment workshops were formed and risk was discussed in the context of the functions that would be relevant to the business units going forward. It is very beneficial to leverage what is available from the vendor on the specifics of the ERP system as the requirements are created. ![]() The concepts in the whitepaper were easily translated by the non-SAP specialist business units and then filtered for applicability to our business model. The project team used the SAP whitepaper “Complying with US FDA Title 21 CFR Part 11 for the Life Sciences Industry,” as a starting point for the team providing insight into SAP functionality. It was essential that the project team agreed on the specific high level risks and functions that one would expect an ERP system to control. Using a transaction code enables quicker access to any task in the system.Ī system risk assessment (RA) was prepared early in this project before the URS (user requirement specification) was written. This strategy can be incorporated into any validation plan or equivalent.įor the purpose of this case study, the risk was broken down into the following three components:Įach function in the system has an associated code. Keep in mind, however, that every system, implementation, organization, and site is different, so rather than focus on “what goes in a validation plan,” focus rather on the various document components that do exist based on the legacy history of the ERP system to determine the rationale, and the approach used to outline a testing strategy. The project team defined and included relevant intended use risks in the risk assessment.Ĭreating a computerized system validation plan is a fundamental building block of any validation project because it outlines the strategy for the entire project. The organization acknowledged that the vendor is an established and recognized business solution provider with a large user base in the industry. As a result, a decision was made, justified, and documented with the rationale for why an audit would not occur. In this case, however, while the system was new to the GMP manufacturing plant, it had been in use supporting the business for 15 years. Therefore, the documentation surrounding the system was essentially non-existent in that it did little to support the use of the system in a regulated environment.Īn important element when purchasing a computer product or service is supplier assessment, which may include supplier audit. The system had not been previously used for GMP purposes. The ERP system discussed in this article, SAP, was a legacy system. GAMP 5 defines a computerized system as: “A computerized system consists of the hardware, software, and network components, together with the controlled functions and associated documentation.” Based on this definition, a holistic approach was used in the implementation of the ERP system as described below.
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