21 CFR Part 11 Compliant Software Package

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.

The SPS/Vsorp standard software

The standard version of the SPS/Vsorp software already complies with the basic requirements for electronic records. The software file format

• is binary-coded
• is very compact
• is destroyed when changed
• can only be read with the SPS/Vsorp software

For further processing, data is imported into Excel^®. The Excel^® spreadsheets grant unrestricted access to all tabular and graphical data. The original data remains unchanged and serves as reference. Thus, full traceability of the Excel^® data is guaranteed.

Additional 21 CFR Part 11 software package

In a GLP or GMP certified environment, the SPS/Vsorp standard software does not meet the requirements for trustworthy and reliable electronic records. Here, the 21 CFR Part 11 compliant software package is available.

User log und electronic signature

The SPS/Vsorp 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. A user that has been inactive for 30 minutes or logged off is prompted to log in again at the next action.

Extended Functionality

• 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

CFR manager

Program for the management of users, data and measurement methods. Only the 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”

Data visualisation

The coded data can be visualised with the SPS/Vsorp Viewer. Visualisation of project data in the SPS/Vsorp Viewer is the same as in the SPS/Vsorp software. Import into an uncoded Excel^® spreadsheet is possible, too. In addition, the SPS/VsorpViewer shows the user log, error log and balance log.

Printing

With the SPS/Vsorp Viewer, the data can be securely printed. Comments can be entered in the “Comment” field and the data to be printed is selected via checkboxes.

The 21 CFR Part 11 compliant software package is available for the instruments of the SPS series as well as for the Vsorp series.