Guide · 7 min · 2026-07-23
Electronic signatures for Part 11–style programs
Plain-language themes pharmaceutical teams should expect from electronic signatures—accountability, meaning, and audit trails—without claiming automatic regulatory approval.
Signatures need meaning
A casual click is not enough when your SOP requires a controlled identity and a clear reason for signing. Ask how signature meaning is captured and displayed.
Accountability you can defend
Who signed, when, and on which version of the record should be obvious in the trail. Shared passwords and generic accounts fail that test.
Corrections stay honest
Regulated records need governed correction patterns—not silent edits. Inspectors care how mistakes are fixed.
Your validated state decides compliance
Software can support Part 11 and Annex 11 themes. Your procedures, validation, and operation decide whether you meet regulatory expectations. Vendors should not claim automatic approval.
How to evaluate Novaqis
Walk a document approval and a quality closure with the audit trail open. Confirm dual-signature needs match your SOP wording where required. Contact us for a live review.
Ready to see Novaqis on your terms?
We prefer live walkthroughs over generic slides. Ask for a demo or a tailored quote—no published list prices.