MS Excel is a versatile application used frequently for GxP-relevant purposes. However, the downside of flexible application possibilities is the numerous risks that arise. The starting point for GxP compliance is a sufficient knowledge and understanding of the risks of Excel applications.
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.
GAMP 5 replaced the term "validation" with "verification", and is used from here onward. Different types of ESS require an adapted risk-based verification procedure that generally follows these principles:
Template applications are the "classics" among Excel spreadsheets and must be verified in every case. Data is handled according to a standardized procedure and saved as a single document. One typical use case in the evaluation of QC test data. It is critical here that calculations be correct. Verification by simple recalculation using a calculator is not sufficient. ESS verification should confirm that it operates reliably over the entire specified application range. Excel-specific risks such as the Excel option "Set precision as displayed" should be mastered.
It is also important to address the following: Are data outputs calculated using the saved template or only printed?
Storage in a thematically appropriate directory is convenient, obvious and often synonymous with the end of secure data integrity. How do I know that the file is still in the unaltered original state when I open it later?
Your first step should then be to ask: Will the electronic data still be required at a later point in time?
If so, steps must be taken that prevent generated data from being deleted. 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.
Disposable ESS are ad-hoc single-use applications. Excel is used like a calculator and worksheets are not saved. The formulas used must be documented, say by attaching a printout of the formula view, and they must be verified as correct. This does not require checking the formula functions for accuracy. The traceability of ESS must be safeguarded by clearly stating the arithmetic calculations carried out from time to time.
In some use cases, it is also useful to save an ESS and treat it as a document. The requirements for calculations are similar to those for single-use ESS and requirements for clear documentation as is customary for text documents, such as adequate change control. One way this can be achieved is via a document management system.
"Small databases" are another very common form of Excel spreadsheets, which are used for storing and managing GxP data. They focus verification on data integrity and the audit trail. 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. The general GAMP 5 recommendation is that users be aware of the weaknesses and limitations of a spreadsheet program for such applications. Combining such awareness with the necessary knowledge will produce an objective risk analysis and the appropriate measures to compensate for the weaknesses. Acceptable, tailor-made ESS solutions with an audit trail can be created on this basis. Opinions differ regarding the audit trail functionality embedded in MS Excel. Any elaboration on this in detail would be excessive at this point, other than to offer an opinion: The weak points frequently mentioned by critics, e.g. "the audit trail can be deleted", or "Excel users can be edited", etc. are manageable. With an overall concept that exploits the existing possibilities and brings the weaknesses under control, an adequate audit trail can be carried out with the on-board tools embedded in Excel. This does not require VBA code, external programs or add-ins.
A standardized verification procedure covering the Excel-specific risks has proven effective for Excel spreadsheets in GAMP categories 3 and 4. Ideally, a high-quality, optimized verification documentation for GxP-relevant Category 4 ESS can be mapped in two documents. In any case, a Category 5 ESS requires more of a verification effort than one of Category 4 with the same range of tasks.
Compliance and efficiency are important pillars for the verification of Excel spreadsheets. We are happy to provide you with competent support for your MS Excel issues with regard to training, cost-efficient strategies or assistance with validations or verifications.
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