Are your MS Excel files validated in a GxP-regulated environment?

In operational practice, Excel® files are often used by a large number of users with varying levels of experience and qualification. The high flexibility and broad availability of MS Excel® enable quick and individual solutions, but at the same time pose significant risks – especially concerning data integrity, traceability, version control, and the reliability of calculations.

A thorough understanding of these risks and their systematic assessment are essential prerequisites for compliance with GxP requirements. The GAMP® 5 guide (2022) specifically addresses this topic in Appendix S3 ("End User Applications Including Spreadsheets") and describes in detail how Excel® applications should be classified based on risk and appropriately validated.

An unreflected or uncontrolled use of MS Excel® in GxP-regulated areas constitutes a breach of duty of care and is regularly regarded by regulatory authorities as a GxP-relevant deficiency. Missing specifications, insufficient testing, or poor documentation can directly impair the quality of processes and products.

Against this background, a structured and professional handling of Excel® spreadsheets according to the principles of computer system validation is indispensable. This includes a risk-based approach throughout the entire lifecycle – from requirements definition through validation to operation and change control.

We will show you how to specifically expand your quality management system with suitable guiding documents and establish an efficient, pragmatic, and GMP-compliant validation of Excel® applications within your company.