Spreadsheet Validation

CSV Compliance

Spreadsheet Validation for 21 CFR Part 11

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21 CFR Part 11 Compliance for Excel

The DaCS Software provides audit trails and audit trail review capability within your Excel workbooks,   providing you with regulatory compliance for your spreadsheets…
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Spreadsheet Validation

Get an overview of how CSV Compliance can help you validate your spreadsheets validation for FDA compliance, or allow CSV Compliance to undertake the validation for you. Learn about a cost-effective and efficient spreadsheet validation process…
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Spreadsheet Validation Services

Get an overview of how to undertake spreadsheet validation for FDA and regulatory compliance, or allow CSV Compliance to undertake the validation project for you. Learn more about a cost-effective and efficient spreadsheet validation process…..

Microsoft Excel can be brought into compliance with 21 CFR Part 11 using DaCS. DaCS has been the leading software for proving spreadsheet validation for 21 CFR Part 11 compliance in pharmaceutical, clinical research and life sciences companies since its introduction in 2001…..

Our Services for Spreadsheet Validation


CSV Compliance is the global leader in spreadsheet validation services for the Life Sciences and regulated industries.

Microsoft Excel can be brought into compliance with 21 CFR Part 11 using DaCS. Finsbury Solutions DaCS

CSV Compliance have developed three industry papers that detail how to do Spreadsheet Validation. David Harrison of

CSV Compliance can help you develop easy to validate VBA macros for Excel and spreadsheets that maximise

World Leaders in Validation Methodology. Learn how to do Spreadsheet Validation. Why risk a resource intensive project

 21 CFR Part 11 Compliance for Excel can be achieved by using DaCS and our Installation and

21 CFR Part Compliance for Excel,

DaCS Software provides audit trails and audit trail review tools

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Our Clients


Our Team


David Harrison
David Harrison
Managing Director
David specializes in pharmaceutical compliance and computer system validation. He is widely recognised as the leading industry
Glenn Ellis
Glenn Ellis
Senior Consultant
Extensive experience developing off-the-shelf and bespoke computer systems with particular expertise within Visual Basic, SQL Server, Microsoft
Finsbury Solutions
Finsbury Solutions
Business Partner
Powerful, reliable spreadsheet risk and end user computing solutions... Finsbury Solutions provides software, consultancy and training in

FDA Warning Letters


…your firm failed to have adequate procedures for the use of computerized systems used in the QC laboratory….. The investigator noticed that the current QC computer users are able to delete data acquired. In addition, the investigator found that there is no audit trail or trace in the operating system to document deletions. Additionally the investigator noticed that the use of the Excel spreadsheets in analytical calculations are neither controlled nor protected from modifications or deletion. The investigator noticed that the calculation ……uses an Excel spreadsheet that has not been qualified. We are concerned about the data generated by your QC laboratory from non-qualified and uncontrolled Excel spreadsheets.

FDA Warning Letters

….You stored original data in an “unofficial” and uncontrolled electronic spreadsheet on a shared computer network drive. Your analyst stated that original data was first recorded in this “unofficial” spreadsheet and transcribed later to an “official” form….

FDA Warning Letter

…..you used unprotected Excel worksheets to perform calculations and statistical evaluations of production data, such as standard deviation and process capability. These electronic files were not secured to prevent unauthorized changes, and have no change history…..

FDA Warning Letter

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