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You are here: Home / Dynamic Vapor Sorption (DVS) Analysis / DVS accessories and options / 21 CFR Part 11 Compliant Software Package

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.

Contact us for more information on the 21 CFR part 11 compliant software package

Request Info

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        Please send me a quotation for

        item no. Description quantity package size
        100913 sample dishes 18 mm box (100 pieces)
        100914 sample dishes 33 mm box (100 pieces)
        100486 sample dishes 50 mm box (100 pieces)
        100916 sample dishes 86 mm box (100 pieces)
        100917 distance pieces set (12 pieces)
        101867 mesh cover 50 mm set (12 pieces)
        101596 PTFE inserts set (12 pieces)
        100485 secondary sample dishes 38 mm box (10 pieces)
        100910 sample carousel 5 sample positions piece
        100908 sample carousel 11 sample positions piece
        100909 sample carousel 23 sample positions piece

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              Please send me the following Application Note / White paper

              Application Notes

              Food

              AN_20-01 Amorphous lactose in food
              AN_20-02 Amorphous fractions in sucrose and sucrose containing model food systems
              AN_20-03 Deliquescence and deliquescence lowering of food ingredients and blends
              AN_20-04 Dehydration behavior of bread crumb and crust

              Pharma

              AN_20-05 Amorphous lactose in the pharmaceutical industry
              AN_20-06 Hydrate formation of L-lysine HCl
              AN_20-09 Hydrate formation of creatine

              Building materials

              AN_20-07 Water vapor sorption of plaster

              Permeability of Packaging material and Foils

              AN_12-01 Water vapor permeability of films

              AN_15-01 Water vapor sorption of product packages

              White Papers

              Universal

              WP_20-01 Amorphous content lactose

              Food

              WP_20-02 Amorphous fractions in sucrose and sucrose containing model food systems
              WP_20-03 Deliquescence and deliquescence lowering of food ingredients and blends

              Pharma

              WP_20-06 Hydrate formation of L-lysine HCl

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              By clicking on the button "Submit", you are authorizing ProUmid GmbH & Co. KG to make use of the entered data in the contact form for contacting you so that we may answer your request and to provide you with information on the requested products and services. We will not pass your personal data to third parties. You will be able to unsubscribe from all of our e-mails at any time. Please have a look at our privacy policy for more information on how we use your data.