Electronic Signatures
Part 11 signatures with name, date, time and signing meaning.
Electronic Signatures binds every entry, verification, review and approval to the authenticated user and to the specific meaning of that action, in line with 21 CFR Part 11 and EU GMP Annex 11 requirements.
What Electronic Signatures delivers
A controlled path from start to closure
- 1Present Record
- 2Authenticate
- 3Select Meaning
- 4Sign
- 5Record
- 6Lock
Why teams move to Electronic Signatures
Meet 21 CFR Part 11 and EU GMP Annex 11 signature requirements
Remove ambiguity over what a signature was intended to confirm
Prevent signature reuse or delegation outside authorised limits
Provide non-repudiable evidence of who approved what and when
Eliminate wet-ink signature chasing across shifts
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.