Vi-CELL MetaFLEX Supports 21 CFR Part 11 Compliance

The Electronic Records and Electronic Signatures Rule (21 CFR Part 11) was established by the Food and Drug Administration (FDA) to define the requirements for submitting documentation in electronic form and the criteria for approved electronic signatures. Since analytical 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-CELL MetaFLEX features the following key system components to facilitate 21 CFR 11 compliance:

Sample results log: 2000
Activity log: 5000
Calibration adjustment log: 1000
Data secured by password protection
Electronic signature capability
Secure user sign-on
8 user level permissions
Administrative configuration tools

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

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.

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.

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

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.

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