Electronic Signatures
Meaning-bound signatures at every controlled decision point.
Electronic Signatures binds identity, timestamp and stated meaning to every controlled decision in the batch record — dispensing, stage completion, review and release — with re-authentication enforced at the point of signing.
What Electronic Signatures delivers
A controlled path from start to closure
- 1Trigger Signature Point
- 2Re-authenticate
- 3Confirm Meaning
- 4Sign
- 5Bind to Record
- 6Verify Completeness
Why teams move to Electronic Signatures
Eliminate wet-ink signature chasing between shifts
Ensure every signature is bound to a stated meaning
Support 21 CFR Part 11 non-repudiation requirements
Verify signature completeness before batch release
Provide inspectors an unambiguous signature audit trail
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.