Can we use a standard ISO 9001 system for Medical Cannabis?

While ISO 9001 is a good foundation, Swissmedic and EU authorities require a system that specifically integrates GACP and EU-GMP. I design systems that bridge these worlds to ensure patient safety and regulatory compliance.

How do you handle the validation of automated cultivation systems?

I apply GAMP 5 principles to HVAC and irrigation software, ensuring automated systems are fully validated and compliant to prevent findings during official inspections.

What is the biggest mistake startups make during QMS buildup?

Creating a 'Paper Tiger'—a system too complex for the operational team. I focus on Operational Integration, building lean SOPs that staff can actually execute in the greenhouse and lab.

Do you perform independent third-party audits?

Yes. Independent third-party audits of suppliers, service providers, and partners are conducted, including GMP, GDP, ISO 13485, and GACP audits.

How are audit findings documented?

Audits are concluded with structured, written audit reports that clearly document observations, findings, and regulatory relevance.

Is a draft audit report provided before finalization?

Yes. A draft version of the audit report is provided to the client for review, including one round of factual clarification before finalization.

Do you assess data integrity during audits?

Yes. Data integrity principles and controls are assessed where applicable, with reference to ALCOA+ expectations.

In which languages are audits and trainings conducted?

Audits and training sessions are available in both English and German.

Do you provide GMP training?

Yes. GMP training is provided covering fundamentals, advanced topics, inspection preparation, audit behavior, and data integrity.

Establishing Audit-Ready QMS for Medical Cannabis Operations

From Cultivation to Distribution: Swiss-Made Precision for the Emerging Cannabis Industry.

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Modern conference room with a large table and chairs, glass wall revealing a laboratory with medical or scientific equipment, and a window showing indoor cannabis plants labeled 'GACP' and 'GMP'.

The medical cannabis market is moving from a 'gold rush' phase to high-level pharmaceutical scrutiny. Regulatory bodies like Swissmedic and EMA now demand full EU-GMP compliance. With 30 years of experience in Life Sciences, I bridge the gap between agricultural cultivation and pharmaceutical excellence, ensuring your system is built for the first inspection—and every one thereafter.