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 optional SPS/Vsorp software extension meets these requirements and enables secure, transparent, and compliant documentation.
- Compliance by Design
- Secure User Management
- Complete Data Traceability
- Seamless Integration
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. Therefore, the 21 CFR Part 11 compliant software package is available.
Additional 21 CFR Part 11 Software Package
- 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.
- 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. Import into an uncoded Excel® spreadsheet is also possible.
- 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.
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proUmid specializes in the manufacturing and worldwide distribution of systems for measuring the sorption properties of materials, as well as humidity generators for analytical applications. Our devices and instruments are used globally in a variety of different applications for water vapor sorption and for regulating relative humidity in analytical instruments.