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…
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…
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
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.
….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….
…..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…..