SERVICES
We serve as your external consulting partner for compliance readiness and remediation endeavors.
We offer top-tier consultants, quality experts, and advisors, all deeply committed to addressing your quality-centric challenges.
Our Simplified by Design C&Q Approach
Risk Early in the Lifecycle
Phase 1 – Concept Define
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Purpose: Identify critical process and system risks to right-size validation requirements.
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Outcome: Front end loading definition of risks to patient and product quality.
System Readiness: URS
Phase 3 - Build
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Purpose: Focus resources and efforts on critical risks.
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Outcome: Timely and robust system readiness.
Verify Process Performance
Phase 5 - Validate
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Purpose: Produce data that confirms process consistency with a focus on CQAs.
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Outcome: Accelerate path to commercialization.
Embed Quality by Design – Integrate CQV & QbD
Phase 2 - Design
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Purpose: Build Design Space.
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Outcome: Design aligned with critical design elements (CDEs).
Risk -Based Testing
Phase 4 - Test
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Purpose: Leverage testing from FAT, SAT, and Commissioning.
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Outcome: Expedited Verification/Qualification.
Sustain Validated State
Phase 6 - Operate
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Purpose: Maintain continuous process monitoring through CPV and Periodic Reviews.
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Outcome: Stable, compliant, audit-ready operations.
