Electronic Batch Release
QP release with certificate generation and ERP update.
Electronic Batch Release verifies completeness, limits, signatures and reconciliation automatically, then routes the record to the qualified person for the final disposition decision, certificate generation and ERP update.
What Electronic Batch Release delivers
A controlled path from start to closure
- 1Validate Completeness
- 2QA Approve
- 3QP Review
- 4Release Decision
- 5Sign
- 6Generate Certificate
- 7Update ERP
Why teams move to Electronic Batch Release
Shorten batch release cycle time significantly
Ensure the qualified person reviews a fully validated record
Remove manual certificate preparation after release
Keep ERP release status synchronised automatically
Provide a defensible, signed release decision 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.