Vi-CELL MetaFLEX Supports 21 CFR Part 11 Compliance

Vi-CELL MetaFLEXCustomer Responsibility: Compliance with 21 CFR Part 111 can only be met in connection with the operational environment. The requirements for such an environment include:

  • Technical environment and data management
  • Training
  • Administration
  • Standard Operating Procedures (SOP)

   
Vi-CELL MetaFLEX Software supports the following 21 CFR Part 11 Requirements2

  • 11.10 (a), (b), (d), (e), (f), (g)
  • 11.50, 11.70
  • 11.300 (a)

   
The software supports the following 21 CFR Part 11 requirements with support of the customer.

  • 11.10 (c), (h), (i), (j), (k)
  • 11.100 (a), (b), 11.200 (a), 11.300 (b), (c), (d), (e)

    
The software supports electronic signatures.

11.10

   
(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand

  • Vi-CELL MetaFLEX provides an IQ/OQ offering
  • Audit Trail for each result file. Record any alterations made to the result file. The actual result for a parameter cannot be modified, but comments or parameters can be added or removed from the report by User(s) with the appropriate permission level
  • Each result file is date and time stamped
  • Data is saved in an encrypted database
  • Data can be archived

    

vi-cell metaflex software audit Trail for each result file 21 cfr part 11 compliance

Figure 1. Audit trail for each result

 

11.10

(b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency.

(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.

Data can be printed on-demand
Data can be displayed on the screen
Data is stored onboard
Up to 2000 results files can be stored onboard
Data can be automatically archived on-board or to an external storage device
Data can be retrieved from an archived file and displayed on the screen
Data can be retrieved from an archived file and printed on-demand

11.10

(b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency.

(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.

  • Data can be printed on-demand
  • Data can be displayed on the screen
  • Data is stored onboard
    • Up to 2000 results files can be stored onboard
  • Data can be automatically archived on-board or to an external storage device
  • Data can be retrieved from an archived file and displayed on the screen
  • Data can be retrieved from an archived file and printed on-demand


11.10 (d) Limiting system access to authorized individuals.
11.200 (a)
11.300 (a)

  • The MetaFLEX provides the following Logon Procedures
    • Log on with a typed entry of Operator name and Password
    • Log on with a logon-barcode
  • Specify Log off Time

vi-cell metaflex software user authentication security profiles 21 cfr part 11 compliance

Figure 2. User authentication security screen

 

11.10

   
(d) Limiting system access to authorized individuals.

(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.

(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand

11.70 Signature/record linking

  • Operators and passwords
    • Ability to add and remove persons
    • Unique ID for the person and password
  • Profiles
    • An access profile specifies what an operator with the given profile can do on the analyzer
      • The operations that can be done
      • Specify menus and screens that can be opened
      • The shortcut buttons that are available to operators
  • Specify mandatory review, approval of results
    • Electronically sign results

     

vi-cell metaflex software operators and passwords settings 21 cfr part 11 compliance

Figure 3. Operators and passwords setup

 

vi-cell metaflex software access profiles actions for selected profiles 21 cfr part 11 compliance

Figure 4. Permitted actions for profile types

 

11.10 (d) Limiting system access to authorized individuals.

  • Activity Log
    • Track all activities on the analyzer
    • Filter to track activity by operator type or by individual user

vi-cell metaflex software user manager service activity log 21 cfr part 11 compliance

Figure 5. User activity log screen

 

References

  1. Electronic Code of Federal Regulations, e-CFR data is current as of February 23, 2017 http://www.ecfr.gov/cgi-bin/text-idx?SID=7d7beb91afce4a519caf5a4217f2910d&mc=true&tpl=/ecfrbrowse/Title21/21cfr11_main_02.tpl
  2. Vi-CELL MetaFLEX IFU PN B95790
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