Pharma: Equipment Qualification with Computerized System (CQV + Annex 11)
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 Sterilization Equipment Requiring Dual Compliance Across CQV and Annex 11
Qualification of a sterilizer/autoclave with PLC/SCADA controls demands compliance across two overlapping frameworks — Annex 15 equipment lifecycle and Annex 11 computerized system validation. High risk arises from the direct impact on sterile assurance, with computerized controls requiring validated security, audit trail, and change control coverage beyond standard equipment qualification.
High risk due to direct impact on sterile assurance from equipment and control system failures
Computerized PLC/SCADA controls require Annex 11 validation in addition to CQV
No validated audit trail or access control coverage for parameter and record changes
Dual-framework compliance gap: Annex 15 lifecycle stages not aligned with Annex 11 requirements
The Strategy
Integrated CQV and Annex 11 Validation Across Full Equipment Lifecycle
The validation scope covered IQ/OQ/PQ for the equipment alongside validation of all computerized system aspects — including audit trails, access controls, and parameter management. Testing followed Annex 15 lifecycle stages (URS, DQ, FAT/SAT, IQ, OQ, PQ) with computerized system controls validated in parallel per Annex 11.
Follow Annex 15 lifecycle stages: URS, DQ, FAT/SAT, IQ, OQ, PQ
Validate computerized system controls per Annex 11: security, audit trails, and change control
IQ/OQ/PQ protocols designed to cover both equipment performance and system control integrity
I’ve worked with many others and you’re way ahead of anything I’ve seen.
Pharma Manufacturing Client
The Solution
Fully Qualified Sterilizer with Validated Computerized Controls Preventing Unauthorized Changes
The equipment meets acceptance criteria across all operating ranges, with computerized controls validated to prevent unauthorized parameter and record changes. The integrated CQV and Annex 11 approach delivers a single qualified system that satisfies both equipment lifecycle and electronic system regulatory expectations.
Equipment meets acceptance criteria across all defined operating ranges
Computerized controls prevent unauthorized parameter changes and record modifications
Audit trail, access control, and change control validated per Annex 11 requirements
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