The general GAMP 5 recommendation is that users be aware of the weaknesses and limitations of a spreadsheet program for such applications. A comprehensible, well-structured and user-friendly architecture combined with a limitation on the ability to edit and the number of users reduce the risk of errors. They focus verification on data integrity and the audit trail. "Small databases" are another very common form of Excel spreadsheets, which are used for storing and managing GxP data. In addition, subsequent changes to the electronic data must be effectively prevented and / or kept under control and monitored by setting up an audit trail. If so, steps must be taken that prevent generated data from being deleted. Your first step should then be to ask: Will the electronic data still be required at a later point in time? How do I know that the file is still in the unaltered original state when I open it later? Storage in a thematically appropriate directory is convenient, obvious and often synonymous with the end of secure data integrity. It is also important to address the following: Are data outputs calculated using the saved template or only printed? ![]() Excel-specific risks such as the Excel option "Set precision as displayed" should be mastered. ESS verification should confirm that it operates reliably over the entire specified application range. Verification by simple recalculation using a calculator is not sufficient. It is critical here that calculations be correct. One typical use case in the evaluation of QC test data. Data is handled according to a standardized procedure and saved as a single document. Template applications are the "classics" among Excel spreadsheets and must be verified in every case. Excel spreadsheets that are only used for creating tables without calculations may be regarded as documents if they are subject to the rules applicable to documents in the GxP environment. If VBA macros are used, category 5 (customer-specific application) is the appropriate classification in most cases. The boundaries are fluid: Many Excel Spreadsheets perform multi-functional tasks and, if developed without using VBA functions in macros, fall under category 4 (configured products). A simple ESS, which performs calculator-like computations via system-specific functions, can be assigned to category 3 (standard software). The GAMP category of an ESS depends primarily on its complexity GAMP exerts no binding specifications in this case. If GxP-relevant data is processed in ESS, there is typically an unsustainable GxP risk if adequate validation is not achieved. ![]() The good news is: Validation of the MS Excel program in your company is not required, as it is part of the qualified infrastructure in your company.Įxcel spreadsheets (ESS for short), however, are assigned to the end user applications in accordance with GAMP® 5. MS Excel is the application environment for Excel spreadsheets and should be considered GAMP category 1 (Infrastructure Software). In practice, this is often used by a wide group of people with different levels of knowledge. MS Excel can be used for a wide range of tasks due to its high level of flexibility and performance.
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