eSignature & Version Control (21 CFR, Part 11) - The signed electronic records contain the name of the signer, the date and time the signature was executed, the meaning associated with the signature and a statement that the user has read, listened to or viewed the material and understands its meaning, and confirms this by electronic signature. The signed electronic records meet the "electronic signature linking" requirement of 21 CFR Part 11 that specifies that if the electronic signature is tampered with, or the file containing the signature is separated from the transaction record, the tampering is evident. Full Details

eSignature & Version Control provides the following capabilities:
1. If a course or document carries an attached test, the system has the capability for forcing the test to be repeated until the users achieves a passing score, at which time the electronic verification process is invoked. If the test is set to "single-try", "limited-tries" or "limited-tries with a time gap between tries", and the user fails the exam, a failure notice is sent to user's supervisor.
2. The system allows administrators to change all passwords, system wide, on a periodic basis.
3. The system contains a time-stamped and unalterable audit trail that records the date and time of user entries that create, modify or delete electronic records.
4. The system allows administrators to establish automatic distribution lists for courses, documents, tests or surveys. Upon significant update of content, the system administrator may direct the system to automatically redistributed the revised content to those on the distribution list for re-verification.
5. The system allows the generation of accurate and complete copies of verification records suitable for inspection, review and copying by the FDA.
6. Access to the system is by role-base authority.
7. Version-Control allows the system to time-stamp exactly which version of a course, document, test or survey the user read, viewed or listened to, and to permanently link that version to that user's history in a way that the user can not readily repudiate the signed record as not genuine.
8. Version control allows you to verifiably remove (or prevent from use) obsolete content from circulation, while maintaining historical documentation.