V-Comp can be part of your lab's compliance strategy for 21 CFR Part 11 when it is setup and operated in Compliance mode. It has been developed under a quality management system and validated with a suite of quality assurance tests. The table below summarizes how the key elements of Part 11 relate to V-Comp and its use in Compliance mode settings.
| Section | Summary of Rule | Compliance Strategy |
| 11.10 | Controls for closed systems | V-Comp can be accessed only through the user interface; it is a closed system. |
| 11.10 (a) | Validation and accuracy. | V-Comp uses externally-generated data to validate its results and employs proprietary binary format, static PDF, and/or CRC methods to ensure valid files. |
| 11.10 (b) | Record generation and readability | V-Comp generates setup and export reports in a designated pathway. The reports are human-readable and machine-readable. |
| 11.10 (c) | Record protection and retrieval | Reports and setups are automatically archived. Record retention and retrieval plan is managed by the laboratory’s file management practices. |
| 11.10 (d) | Authorized access | V-Comp uses the operating system’s user login validation, and user group membership determines permissions within the software. |
| 11.10 (e) | Audit trails | V-Comp has a logging system with time stamps, and log files are preserved. Log files cannot be deleted within the program. |
| 11.10 (f) | Operational system checks | V-Comp uses a guided sequence of user actions to enforce permitted sequencing of steps and events. |
| 11.10 (g) | Authority checks | V-Comp uses the operating system user groups and login validation to assure authorized access. |
| 11.10 (h) | Device checks and validity | V-Comp performs validation checks on the source data files. |
| 11.10 (i) | Education, training and experience | V-Comp provides a User Guide, guided analysis steps, and tutorial videos to assist with the proper, intended use of V-Comp. Additional on-site training may be arranged. |
| 11.10 (j) | Electronic signatures | This is an individual laboratory requirement beyond the scope of use of V-Comp. |
| 11.10 (k) | Systems documentation | V-Comp version releases are accompanied by an updated User Guide. Verity employs document control procedures. |
| 11.30 | Controls for open systems | V-Comp is designed as a closed system. |
| 11.50 | Signature manifestations | V-Comp does not require or offer electronic signatures. |
| 11.70 | Signature linking | V-Comp does not require or offer electronic signatures. |
| 11.100 (a) | Unique electronic signatures | Your laboratory must ensure that electronic signatures are unique to each user on the network. |
| 11.100 (b) | Identity verification | Each laboratory must verify its own employment records and IDs. |
| 11.100 (c) | Signature verification | Each laboratory must verify electronic signature eligibility with the FDA. |
| 11.200 (a)(1) | Two-component signing | V-Comp does not require or offer electronic signatures. |
| 11.200 (a)(2,3) | Authenticity and falsification | V-Comp does not require or offer electronic signatures. |
| 11.200 (b) | Biometric signatures | V-Comp does not utilize biometric IDs. |
| 11.300 (a) | Controls for identification | V-Comp uses the operating system user groups and login validation to assure unique user identities. |
| 11.300 (b) | Identification aging | The individual laboratory IT structure must control password checks and aging requirements. |
| 11.300 (c) | External ID validation | Not applicable. V-Comp does not utilize external tokens, cards, RFID, or other physical identity-confirming devices. |
| 11.300 (d) | Unauthorized use | The individual laboratory IT structure must control login authenticity and safeguards. |
| 11.300 (e) | External device testing | Not applicable. V-Comp does not utilize external tokens, cards, RFID, or other physical identity-confirming devices. |