Desktop Spreadsheet Control and FDA 21 CFR Part 11 Compliance

DaCS provides a seamless infrastructure for MS Excel to meet regulatory compliance requirements through its detailed change history, audit trail, security enhancements, and electronic signature capabilities.

DaCS was the first commercial product specifically designed to address FDA 21 CFR Part 11 compliance issues with Microsoft Excel. Introduced in 2001, DaCS has been implemented by many of the leading clinical research, pharmaceutical manufacturing, and other companies worldwide to bring their critical spreadsheets under control.

To learn more about how to meet the Part 11 requirements see our white paper Finsbury’s Guide to spreadsheets and FDA CFR 21 Part 11.

Key features of DaCS include:

  • The ability to continue to use the convenience and common functionality of Excel in a compliant regulatory environment.
  • Non-intrusive solution allows users of Excel to be given access to DaCS controlled files such that the user will be able to open and read the data, but not make any modifications.
  • Easy to implement, including the ability to import your current spreadsheets into the secure DaCS environment with no or minimal modification.
  • Increases security of critical business information through logical security features that control access to DaCS and to each individual spreadsheet.
  • Provides accountability framework including the ability to execute secure electronic signatures within individual workbooks, eliminating the need for signed paper copies.
  • Creates robust documentation with a fully independent audit trail recording who, when, and what changes are made that is securely incorporated within individual workbooks, allowing complete portability without losing the traceability of the workbooks history.