Regulatory agencies require laboratories to have solid protection for their Excel spreadsheets. MHRA, the FDA and UKAS, to name but a few, demand proof of total control over the security of calculation tools and the accuracy of data.

Raw data sheets

Excel is very practical for automating calculations in laboratories. Once the raw data sheet is checked by a supervisor, it should then be firmly locked, but remain accessible thus becoming a real electronic record.

Control charts

This type Excel spreadsheet is used to monitor the evolution of a measurement over a certain period of time. What is difficult is to automatically track changes made to the sheet, giving you total command over control charts and indeed all your other data storage sheets.

Monography

Often monographs or specifications are written using Excel. In this case, it is crucial to have total control over the change of spreadsheets versions and their distribution, in order to avoid personal copies being made.

Security aspects

• Audit trail : access, data and printing
• Access management
• Logic security

References taken into account:

• The FDA and the 21 CFR part 11
• The AFSSAPS and the BPF 98, directive line n°5
• ISO/CEI 17025 – Chapter 5-4-7-2 B
• GMP and electronic records.

More details

SecureXLS - Laboratory Application