Electronic Approval Workflow
Sequential or parallel review and approval with Part 11 signatures.
Electronic Approval Workflow routes each annual review through configurable sequential or parallel approval steps, capturing Part 11 electronic signatures and comments before the report is locked and issued.
What Electronic Approval Workflow delivers
A controlled path from start to closure
- 1Route for Review
- 2Comment
- 3Revise
- 4Approve
- 5Sign
- 6Lock & Issue
Why teams move to Electronic Approval Workflow
Replace email-based approval chains with a controlled workflow
Ensure every issued report carries valid Part 11 signatures
Cut approval cycle time with automatic escalation
Provide a complete, auditable approval history per report
Support parallel review to compress overall review time
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.