Excel validation

EXCEL® spreadsheet validation - safe and GMP-compliant applications in the laboratory?

Fast and flexible Microsoft EXCEL® spreadsheets (ESS) are an essential part of analysis operations, despite the advent of highly integrated LIMS and QM systems. Not infrequently, "several" applications are in use at the same time, ranging from simple "stand-alone" systems through in-house development to outsourced, networked and macro-based programming. Commonly, a coherent overview, as well as the risk assessment and validation, are omitted entirely.

All are equal before the law...
This famous quote can also be applied to the validation of EXCEL® spreadsheets. The complexity is irrelevant. The sole decisive factor is their purpose, which determines whether they are GMP-critical. According to the current EU GMP Guide Annex 11 (Section 3.8) draft version, or the U.S. 21 CFR 211.165, the validation of Excel spreadsheets is mandatory.

...and certainly in practice!
The key to success of a customised validation is the consistent application of the "risk-based approach". In particular, the GMP risks ought to be separated from the business risks. Measures that were successfully tested and documented reduce the identified risks, and give the ESS a trusted foundation.

Mastering the applications
The completion of validation does not just provide assurance for inspections. The certainty and the confidence that critical data are mastered safely are even more important. SOPs for the application of the ESS, and corresponding, adequate training measures also help to ensure that daily operations are designed efficiently and comprehensibly. Inventory recording, risk management and validation will make you invulnerable when dealing with EXCEL® spreadsheets.

What are the next steps?
We support you on your path to valid applications. Fast - goal-oriented - qualified.


Click here to see the reference projects "Computerised Systems Validation - Excel Validation"

 For further information please contact Dr. Thomas Karlewski

Chemgineering Business Design AG | Binningerstrasse 2 | 4142 Münchenstein | T +41 61 467 89 00 | F +41 61 467 89 01 | www.chemgineering.com | info@chemgineering.com