Rebuilding your QMS isn’t just about replacing documents—it’s about rethinking how your quality system functions, supports operations, and meets evolving regulatory expectations. We apply a structured, phase-based approach to design and implement a QMS that’s compliant, scalable, and built for long-term success.
This process can be adapted to fit the size and maturity of your company.
Phase 1: Strategic Foundation
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Current State Assessment
Comprehensive evaluation of existing processes, documentation, systems, and compliance status.
Includes stakeholder interviews, audit findings review, and gap analysis. -
Future State Quality System Design
Definition of an ideal future-state QMS aligned to your product types, risk profile, markets, and growth strategy. -
Quality System Architecture
Development of an overarching QMS structure: process landscape, interaction mapping, and document hierarchy design. -
Regulatory Requirements Mapping
Identification of applicable standards and regulations:-
FDA QSR or QMSR
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ISO 13485
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ICH Q10
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EU MDR/IVDR (as applicable)
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GxP regulations
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Country-specific GMPs
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Phase 2: Process & Documentation Development
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Core Quality Process Design
Creation or overhaul of key processes, including:-
Document and change control
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CAPA
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Complaints and nonconformances
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Risk management
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Design control (for devices)
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Supplier quality
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Production and process control
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Internal audits and management review
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SOP System Development
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SOP creation using harmonized templates
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Integration with roles, training, and record control systems
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SOP numbering and metadata standards
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Batch issuance and version control planning
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Role Definition and QMS Ownership Mapping
Clear assignment of process ownership, responsibilities, and cross-functional dependencies.
Phase 3: Implementation & Optimization
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Phased Rollout Planning
Implementation roadmap with manageable phases based on risk, compliance needs, and operational capacity. -
Training and Change Management
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Internal QMS training programs by function and process
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Role-specific onboarding and refresher strategies
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Communication planning for leadership and staff
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Digital QMS and IT System Integration
Requirements definition and support for platform selection (eQMS, LMS, eDoc, etc.), or integration into existing tools. -
Pilot Testing & Feedback Loops
Targeted testing of new processes and documentation to identify practical gaps and optimize before full rollout. -
Post-Implementation Support
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Ongoing troubleshooting and refinement
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Preparation for upcoming inspections or certifications
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Metrics and dashboards for QMS performance monitoring
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