Data security for “Electronic Records” in accordance with CFR21 part 11
Title 21 Part 11 of the Code of Federal Regulations (CFR) deals with the guidelines of the Food and Drug Administration (FDA) of the United States for electronic records and electronic signatures (ERES). Part 11 specifies the criteria under which electronic records and signatures as an equivalent to paper records (Title 21 CFR part 11 section 11.1 (a)) are considered to be trustworthy and reliable.
SPS standard software
The standard version of the SPS software already complies with the basic requirements for electronic records.
The SPS file format
- is binary-coded
- is very compact
- is destroyed when changed
- can only be read with the SPS software
For further processing, the data are imported into Excel®.
The Excel® spreadsheets grant unrestricted access to all tabular and graphical data.
The SPS data remain unchanged and serve as reference.
Full traceability of the Excel® data is thus guaranteed.
SPS CFR 21 package
In a GLP or GMP-certified environment, the SPS standard software does not meet the requirements for trustworthy and reliable electronic records.
Here, the CFR21 part 11-compatible SPS software is used.
User log und electronic signature:
The SPS software with CFR option can only be used when the user is logged in.
Every action of the user which is relevant to the measurement is logged.
If the user has been inactive for 30 minutes or logged off, he/she is prompted to log in again at his/her next action.
- Administration of user accounts and assignment of user rights to the “Administrator”, “Expert” und “User”
- User and data administration by the Administrator including “Secured Data Environment” and “Data Integrity”
- Enhanced logging of the actions of all users including changes in parameters via “Time Stamped Audit Trails”
- SPS Viewer for secure data display and printing
Assignment of user rights:
- The CFR “Administrator” manages the data but has no access to contents
- The „Expert“ is allowed to program new measurement methods and perform measurements
- The „User“ is only allowed to perform measurements
Program for the management of users, data and measurement methods.
Only the SPS administrator can access the CFR Manager.
- New users are set up
- User levels are assigned
- User accounts are activated or locked
- Passwords can be reset
- The “Administrator” can export files and delete them if they are no longer needed
- The “Expert” or “User” cannot delete files
- The “Expert” can create new settings (methods)
- Methods can only be deleted by the “Administrator”
The coded data can be visualised on the user´s personal computer with the SPS Viewer:
- The visualisation of project data in the SPS Viewer is the same as in the SPS software
- Import into an uncoded Excel® spreadsheet is also possible
In addition, the SPS Viewer shows the user log, error log and balance log.
With the SPS Viewer, the data can be securely printed.
- Comments can be entered in the “Comment” field
- The data to be printed can be selected via checkboxes
- A print preview can be displayed via “Preview”