Layout and Data Security

To help you fulfill your requirements under 21 CFR Part 11, 11.10(c), FCS Express provides Record Protection. This is implemented in two forms:

 

1. Your layouts are stored in an encrypted format, and require the correct encryption key to open. This holds true whether or not any data has been embedded in the layout. If the layout has been tampered with, or corrupted in any way, FCS Express will not be able to decrypt it, and will inform you that the layout cannot be opened.  

 

Note that we encourage you to retain secure backups of your layouts if the above situation were to ever occur, so that you would be able to retrieve your analysis.

 

2. When data is loaded in a layout, FCS Express makes a digital signature of the data, and stores it in the layout. After the analysis is completed, if in the future someone attempts to open the layout to look at your analysis, then the layout will only display the data if the digital signature is still the same. In other words, if the data has changed, the person will not be able to see that data in your analysis, and all plots will appear blank. This holds true whether the data was saved embedded in the layout, or is stored separately on disk.