Automated Cell Counter Review Gmp 21 Cfr 11

The Electronic Records and Electronic Signatures Rule (21 CFR Part 11) was established by the Nutrient and Drug Administration (FDA) to define the requirements for submitting documentation in electronic grade and the criteria for approved electronic signatures. Since analytical musical instrument systems such as the Vi-Cell MetaFLEX bioanalyte analyzer generate electronic records, these systems must facilitate compliance with the Electronic Records Rule. The Vi-Prison cell MetaFLEX features the following cardinal system components to facilitate 21 CFR 11 compliance:

• Sample results log: 2000
• Activity log: 5000
• Calibration adjustment log: k
• Data secured by password protection
• Electronic signature adequacy
• Secure user sign-on
• eight user level permissions
• Administrative configuration tools

Six-CELL MetaFLEX Software supports the following 21 CFR Role 11 Requirements²

• xi.10 (a), (b), (d), (east), (f), (grand)
• 11.50, xi.70
• 11.300 (a)

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

• eleven.10 (c), (h), (i), (j), (k)
• xi.100 (a), (b), 11.200 (a), eleven.300 (b), (c), (d), (east)

The software supports electronic signatures.

11.ten

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

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

(grand) Utilize of authority checks to ensure that only authorized individuals can utilize the system, electronically sign a record, admission the operation or calculator system input or output device, change a tape, or perform the operation at hand

• Vi-Prison cell MetaFLEX provides an IQ/OQ offering
• Inspect Trail for each outcome 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 written report by User(s) with the appropriate permission level
• Each result file is date and fourth dimension stamped
• Information is saved in an encrypted database
• Data can be archived

Figure 1. Audit trail for each result

eleven.10

(b) The ability to generate authentic 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 authentic and prepare retrieval throughout the records retentivity flow.

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

eleven.x

(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 bureau.

(c) Protection of records to enable their authentic and gear up retrieval throughout the records retentivity menses.

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

11.ten (d) Limiting organization 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

Figure 2. User authentication security screen

eleven.x

(d) Limiting organization admission to authorized individuals.

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

(g) Employ of authority checks to ensure that but authorized individuals can use the system, electronically sign a tape, access the performance or computer system input or output device, alter a tape, 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 tin can do on the analyzer
    • The operations that tin be done
    • Specify menus and screens that can exist opened
    • The shortcut buttons that are available to operators
• Specify mandatory review, approval of results
  • Electronically sign results

Figure three. Operators and passwords setup

Figure 4. Permitted deportment for profile types

11.ten (d) Limiting system admission to authorized individuals.

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

Effigy 5. User activity log screen

References

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

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Source: https://www.beckman.com/cell-counters-and-analyzers/vi-cell-metaflex/21-cfr-part-11

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