MOD-08 · Platform module
Electronic Approvals
21 CFR Part 11 and EU Annex 11 compliant signatures — without the signature chase.
What it does
Electronic Approvals replaces the wet-ink signature chase with compliant electronic signatures embedded in the flow of work. Protocols, results, deviations and turnover packs move through defined approval workflows with authenticated, time-stamped, meaning-attributed signatures that satisfy 21 CFR Part 11 and EU Annex 11 — and an audit trail that writes itself.
Before and after Electronic Approvals
- Documents printed, signed, scanned and filed — per signature
- Approval status unknown without asking around
- Signature meaning and dating errors found during audit prep
- Compliant e-signatures applied in seconds from anywhere
- Live approval queues — everyone knows what awaits them
- Complete, tamper-evident audit trail on every record
Capabilities
Inside the module
- 21 CFR Part 11 / EU Annex 11 aligned electronic signatures
- Configurable approval workflows per document and record type
- Personal approval queues with notifications and delegation
- Signature meaning, date-time and authentication captured on every signing
- Tamper-evident audit trail across all records
Direct answers
Electronic Approvals — common questions
Are Rowsys signatures accepted by regulators?
Rowsys electronic signatures are designed to the requirements of 21 CFR Part 11 and EU Annex 11: unique authentication, signature meaning, secure time-stamping and tamper-evident records. They are the same class of signature regulators see across modern GMP systems.
Can approval workflows match our quality procedures?
Yes. Approval sequences, roles and required signatories are configured to mirror your SOPs — the system enforces your procedure rather than replacing it.
See the method in practice
See Electronic Approvals on your own scenario.
Bring a live project problem to the demo — we will show you exactly how this module handles it.