Healthcare companies regularly use Microsoft® Excel spreadsheets in lab processes, whether as an operator interface, as a data manipulation tool, or for data storage.

“Failure to use fully validated computer spreadsheets to calculate
analytical results for in-process and finished product testing”
FDA Warning Letter. July, 2001

21 CFR Part 11 and Excel Spreadsheets

FDA Inspectors have sent strong messages to companies that 21 CFR Part 11 compliance should include Excel spreadsheets -- if you are using Excel for lab process activities you must validate each critical spreadsheet to demonstrate the security and traceability of your data. Various “procedural and technical” controls within Excel can improve compliance, but standard Excel functionality DOES NOT allow you to validate to an acceptable standard with respect to data security or 21 CFR Part 11.

Can your current validation verify:

• • An independent audit trail?
• • Log-on security for the application and spreadsheets?
• • That your data is secure and that saved data can not be
•    modified?

Fully Validatable Solution

Compassoft DaCS for Pharmaceuticals allows you to use Excel in a regulated environment by providing you with a fully validatable technical solution to your Excel spreadsheet compliance concerns.

Compassoft DaCS for Pharmaceuticals is an embedded application that integrates seamlessly with Excel, to provide detailed change history via :

• • Real-time data logs
• • Security enhancements
• • Change documentation
• • Electronic signatures controls

Compassoft DACS for Pharmaceuticals Cell Change Audit Trail
(click to zoom)

> Learn More at our upcoming Webinar!