MS Excel can be used for a wide range of tasks due to its high level of flexibility and performance. In practice, this is often used by a wide group of people with different levels of knowledge. MS Excel is the application environment for Excel spreadsheets and should be considered GAMP category 1 (Infrastructure Software). 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.
Excel spreadsheets (ESS for short), however, are assigned to the end user applications in accordance with GAMP® 5. If GxP-relevant data is processed in ESS, there is typically an unsustainable GxP risk if adequate validation is not achieved.
The GAMP category of an ESS depends primarily on its complexity; GAMP exerts no binding specifications in this case. A simple ESS, which performs calculator-like computations via system-specific functions, can be assigned to category 3 (standard software).
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). If VBA macros are used, category 5 (customer-specific application) is the appropriate classification in most cases. 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.