21 CFR Part 11

 

21 CFR Part 11 sets forth the FDA’s standard for electronic signatures and tracking of all changes to your database. Companies that wish to have electronic records and electronic signatures accepted as equivalent to the corresponding paper records must comply with this standard.

FaciliWorks' electronic security features make implementing 21 CFR Part 11 in your workplace simple, straightforward, and secure.

Assured Compliance for Your Company

To better assure our customers of compliance with 21 CFR Part 11, CyberMetrics voluntarily undergoes independent 3rd party audit, review and certification of FaciliWorks. This includes actual on-site inspection of our records, product development practices, testing methods, maintenance procedure as well as specific functional assessment of our software.

Copies of our compliance certification letters are available upon request.

Security

When you install FaciliWorks you are prompted to choose to implement 21 CFR Part 11. The 21 CFR Part 11-compliant version requires security to be active at all times, so from the beginning you must set up users and groups and define their security privileges.

With security active, you can also control which users have access to what forms and even what parts of forms; for instance, you can let workers view the Labor form under Work Orders but hide the Cost field in that form from them. To make security easier to implement, you can create groups with standardized access privileges and assign users to one or more groups as needed.

If you are installing the standard FaciliWorks, security is not required, but you may set up security if you wish. FaciliWorks' 21 CFR Part 11 features such as electronic signatures and audit trail work only when security is active.

Electronic Signatures and Approvals

The 21 CFR Part 11-compliant version of FaciliWorks requires signatures and approval signatures when checklists, work orders, and service requests are completed, and when purchase orders are issued.

Once a record has been signed, it cannot be modified unless the original signer unsigns it; once an approval signature is recorded, the signer of the approval must unsign it before the signer can unsign it.

FaciliWorks maintains a comprehensive history of all signatures on a given record, including date, time, and signer. If the record has been unsigned, that information is recorded as well.

If you wish, for added security, you may require users to log in and enter a password whenever they sign or approve a record. 21 CFR Part 11 installations must log in each time a record is signed, approved, unsigned, or unapproved.

Audit Trail

The 21 CFR Part 11-compliant version of FaciliWorks automatically enables the Audit Trail, which maintains a comprehensive history of all user actions such as record modifications, additions, or deletions, and the user who performed them. This record is preserved indefinitely. Non-21 CFR Part 11 users may have FaciliWorks purge these records after a set number of days have elapsed.

The Audit Log can be viewed onscreen or printed out; if you want to see only certain records, you can search for those records using FaciliWorks' easy-to-use report filters.

© 1998–2004 CyberMetrics Corporation. All Rights Reserved.

Home Products Support Training News About Us Contact Us Site Map