More organizations are moving away from traditional ink and paper-based signatures towards managing this process digitally. There are huge benefits to doing so, but for manufacturers regulated by authorities such as the US Food and Drug Administration and the European Commission it is critical that all labeling and artwork management activities signatures are compliant with both FDA 21CFR Part 11 and EU GMP Annex 11 regulations. Every approval completed using an electronic signature must be done so in a system which meets the strict technical requirements of these regulations.
How does Kallik help with compliant e-signatures?
Electronic signature requirements by major regulated bodies |
Included in Veraciti™ |
Validated computerized system |
✔ |
Ability to retrieve copies of records to present to the agency during audit |
✔ |
Protection and retention of records |
✔ |
Limited and controlled system access |
✔ |
Time stamped audit trails |
✔ |
Electronic records contain the name of signer, time and date and meaning associated with signature |
✔ |
Signatures are unique and cannot be modified or transferred |
✔ |
Users use two identification components, username and password, for every electronic signature action |
✔ |
Unique password and username combinations for every user |
✔ |
Trust Kallik to deliver a compliant solution
Kallik’s unique labeling and artwork management software, Veraciti™ is used by many major medical device manufacturers to ensure e-signature compliance across their labeling and artwork management processes. You can learn more about the other benefits of using Veraciti here.
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