Electronic Signatures
Part 11 signatures on authoring, review and approval steps.
Electronic Signatures applies meaning-bound, Part 11 compliant signatures to authoring, review and approval steps on every controlled document, replacing wet-ink signature pages entirely.
What Electronic Signatures delivers
A controlled path from start to closure
- 1Prepare Document
- 2Sign as Author
- 3Route for Review
- 4Sign as Reviewer
- 5Approve & Release
Why teams move to Electronic Signatures
Meet 21 CFR Part 11 electronic signature requirements
Remove wet-ink signature pages and physical routing
Bind every signature to a clear, stated meaning
Prevent repudiation with enforced re-authentication
Produce signature evidence packs for inspectors instantly
Built for regulated operations
21 CFR Part 11
Electronic records and electronic signature controls — unique user identity, secure e-signatures and computer-generated audit trails on every record.
EU GMP Annex 11
Computerised system controls including access management, change control, data integrity and periodic review of the system.
GAMP 5
Risk-based validation approach, with pre-executed IQ/OQ documentation supplied with every release.
ALCOA++
Records that are attributable, legible, contemporaneous, original and accurate — enforced at record level.
OPS IQ is designed to support these regulatory expectations. Compliance is achieved together with your own validated implementation, procedures and controls.
Connected to your enterprise systems
ERP / SAP
Master data, materials and batch context exchanged over open REST and event APIs.
MES
Shopfloor execution events and equipment context linked to quality records.
LIMS
Laboratory results and specification data connected to quality decisions.
Identity Providers
Enterprise SSO and role-based access through your existing identity provider.
Enterprise APIs
Open REST and event APIs for custom and legacy systems.