Medical Devices: QMSR Transition Impact on Production Software Validation
What we succeed?
As a result of the partnership we established with Validfor, our test cycles shrink from weeks to daysthrough one structured digital workflow and full visibility, traceability and audit rediness.
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The Problem
Legacy Validation Practices No Longer Compliant Under FDA QMSR Adoption Timeline
A medical device manufacturer transitions to FDA QMSR (effective Feb 2, 2026) and must update validation practices across production automation, inspection/test systems, and QMS software — with high compliance impact and a firm regulatory deadline driving urgency.
High compliance impact due to mandatory QMSR adoption timeline (Feb 2, 2026)
Existing validation practices not aligned with FDA CSA risk framework
Production/QMS software systems lacking documented risk classification
No systematic periodic evaluation or modernised change control in place
The Strategy
FDA CSA Risk Framework Applied Across Production and QMS Software Portfolio
The validation scope covered production automation software, inspection and test systems, and QMS software used for quality records — with assurance activities defined and prioritised using the FDA CSA risk framework and aligned to ISO 13485-based QMS expectations under QMSR.
Apply FDA CSA risk framework to classify each software system and define appropriate assurance activities
Confirm alignment with ISO 13485-based QMS expectations under QMSR — documented processes and control
Implement periodic evaluation and modernise change control procedures
Validfor offers unparalleled traceability and control, ensuring that computerized systems remain compliant with industry standards.
Gizem Bozok
Quality Area Manager
The Solution
Risk-Classified Software Portfolio with Objective Compliance Evidence for QMSR
Every software system in scope was documented with its intended use and risk classification. Assurance activities were scoped proportionally to risk, producing objective evidence that each system maintains its validated state — enabling the manufacturer to demonstrate QMSR readiness at inspection.
Intended use and risk classification documented for each software system in scope
Assurance activities produce objective evidence commensurate with risk
Maintained validated state demonstrated across production and QMS software portfolio
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