Medical-device validation experience
Support for Class I, II and III medical-device manufacturing environments, including ERP processes, labeling systems, 3D scanners, new computerized systems, inspection/quality tools, migrations, integrations, and major system changes.
Risk-based delivery can be aligned with applicable quality-system requirements and recognized industry guidance, including GAMP 5, 2nd Edition.
CSV / CSA
GAMP 5, 2nd Ed.
ISO 13485
21 CFR Part 11
Class I / II / III
Human-in-the-Loop
Validation PlanOverall scope, governance, risk-based approach, deliverables, responsibilities and completion criteria.
Software Validation ProtocolExecution framework, testing rules, acceptance criteria, deviation handling and validation controls.
Requirements Traceability Matrix (RTM)Trace requirements through risk, testing, execution results and final disposition.
Business Process CatalogDocument validated business processes, ownership, systems, controls and supporting requirements.
Master Test StrategyDefine the overall testing approach, environments, responsibilities, evidence, defect handling and coverage.
Test Script DevelopmentDevelop risk-based test scripts, including Data Migration Validation Tests and process-specific validation tests.
Test ExecutionExecute or manage controlled validation testing with objective evidence and documented results.
RTM MaintenanceMaintain traceability as requirements, tests, results, deviations and dispositions evolve.
Remediation & RetestingManage deviations, corrections, targeted retesting, regression decisions and final disposition.
Individual Test SummariesSummarize execution, failures, remediation, evidence and final test conclusions.
Validation Summary ReportProvide the final validation conclusion, completion evidence, deviations, traceability status and release recommendation.
Validation Remediation & Maintaining Validated StateRecover incomplete or outdated validation and support ongoing review after system changes, upgrades and enhancements.
Independent Verification & Validation (IV&V)Provide independent evaluation of requirements, testing, traceability, evidence and validation completeness.