Strategic QMS Engineering: Built for Compliance, Proven in Inspections
Designing lean, scalable, and audit-ready Quality Management Systems for the Life Sciences industry.
Schmidt-GMP provides an inspection-oriented approach to QMS design. We bridge the gap between theoretical regulations and practical operations, ensuring that your document architecture and quality processes withstand the scrutiny of FDA, EMA, and Swissmedic.
Framework Design
Custom QMS build-up from ground zero. Compliant with ISO 13485 and GMP.
The Key Benefits
Document Architecture
Site Master Files (SMF) and SOP hierarchies designed with the 'Red Thread' for auditors.
The 'Red Thread' Strategy: Document Architecture for Seamless Audits
In over 30 years and 50+ international inspections, I have seen many QMS fail not because of a lack of quality, but because of a lack of clarity. A pile of SOPs is not a system. My approach focuses on creating a 'Red Thread'—a logical, transparent narrative that guides an auditor through your processes without raising unnecessary questions. We build confidence, not just documentation.
Logical SOP Hierarchies: We structure your documents to ensure clear dependencies and eliminate redundancies, making the system easy to navigate for both staff and auditors.
Lean Quality Manuals: Instead of just repeating regulations, your Quality Manual will serve as a high-level strategic roadmap for your entire organization.
Digital Readiness: We design your document architecture to be 'future-proof,' ensuring a smooth transition to Digital Document Management (DMS) or LIMS systems.
Operational Integration
Hands-on implementation of Deviation Management, CAPA and Change Control that actually works in daily practice.