Pharma Manufacturing: MES Upgrade with Recipe Management and Batch Execution
What we succeed?
As a result of the partnership we established with Validfor, our testing, approvals, documentation, repository in one platform and full visibility, traceability and audit rediness.
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The Problem
High-Risk MES Upgrade Exposing Batch Record Integrity and Patient Safety Gaps
A pharma manufacturing site upgrades its MES system controlling batch records and execution steps — introducing high patient safety and product quality risk alongside high data integrity risk across batch execution, recipe management, and historian/ERP interfaces.
High patient safety and product quality risk tied directly to batch execution controls
High data integrity risk across batch records and electronic signatures
Recipe version control not validated against change control requirements
No validated backup/restore or business continuity coverage for the critical execution environment
The Strategy
End-to-End Batch Execution Validation with Audit Trail and Business Continuity Coverage
The validation scope covered batch record data integrity, electronic signatures, audit trails, recipe version control, and interfaces to historians and ERP — with scripted end-to-end testing prioritised to match the high patient safety and DI risk profile of the MES upgrade.
Scripted end-to-end batch execution tests including exception handling scenarios
Audit trail review and reason-for-change requirement validation
Backup/restore and business continuity tests for the critical execution environment
Recipe version control validated against change control and approval traceability
I’ve worked with many others and you’re way ahead of anything I’ve seen.
Pharma Manufacturing Client
The Solution
Validated MES with Enforced Role-Based Batch Approval and Traceable Recipe Control
The upgraded MES ensures that only authorised roles can release and approve batch records, with every action attributable and time-stamped. Recipe changes are governed by change control and fully traceable to approvals and tests — meeting GMP batch record and electronic signature requirements.
Only authorised roles can release and approve batch records; all actions attributable and time-stamped
Recipe changes controlled via change control and traceable to approvals and tests
Backup/restore capability verified for the critical batch execution environment
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