Electronic Signatures
Part 11 signatures on authoring, review and approval steps.
Electronic Signatures apply meaning-bound, Part 11 compliant signatures to authoring, review and approval steps, capturing the signer's identity, timestamp and stated meaning at every stage.
What Electronic Signatures delivers
A controlled path from start to closure
- 1Prepare Record
- 2Sign as Author
- 3Route for Review
- 4Sign as Reviewer
- 5Approve
Why teams move to Electronic Signatures
Meet 21 CFR Part 11 electronic signature requirements
Remove wet-ink signature delays from the review cycle
Bind every signature to a clear stated meaning
Prevent signature repudiation with enforced re-authentication
Keep signature evidence exportable for inspection
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.