We don’t just write SOPs—we create integrated quality systems that meet regulatory expectations and actually work in practice. Our support typically spans three dimensions: design, implementation, and sustainability, but can be adapted specifically to the needs of your organization.
Design & Architecture
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Gap assessment: Evaluate existing processes, documentation, and regulatory obligations.
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QMS architecture: Define system framework, document hierarchy, and process interactions.
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Core procedure development: Draft essential SOPs covering design, production, change control, CAPA, complaints, and more.
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Supporting materials: Develop work instructions, forms, templates, and the Quality Manual.
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Role definition: Build RACI matrices and governance structures for accountability.
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Implementation & Change Management
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Phased rollout planning: Sequence implementation to maintain compliance while minimizing disruption.
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Training & adoption: Create role-specific curricula, job aids, and onboarding materials.
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System integration: Align processes with existing IT systems (eQMS, LIMS, LMS, etc.) or define requirements for new platforms.
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Change management: Support communication, leadership alignment, and cultural adoption to ensure smooth transitions.
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Sustainability & Continuous Improvement
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Monitoring & metrics: Build dashboards and KPI frameworks for effectiveness tracking.
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Management review process: Establish leadership oversight mechanisms to drive accountability.
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Internal audit program: Develop schedules, tools, and auditor training to maintain compliance.
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CAPA & risk integration: Embed proactive issue management and risk-based decision-making.
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Continuous improvement loop: Ensure your QMS adapts to growth, feedback, and evolving regulatory expectations.
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Specialized Support (When Needed)
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Startup builds: Lean but compliant QMS tailored to early-stage companies.
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Scale-up redesigns: Transition from ad hoc processes to structured systems as growth accelerates.
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Global harmonization: Align QMS across multiple sites or regions under FDA, ISO, EU MDR/IVDR, or ICH Q10 frameworks.
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Digital QMS transitions: Support for migrating from paper-based systems to electronic platforms
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