Compliance solutions for Pharma & Medical Device
We simplify compliance in regulated industries
From technical documentation to GMP qualification, we support machine builders and end users on the path that brings systems, plants and software to full compliance.
SPAIQ at a glance
The regulatory framework is complex. We make it manageable with strategic consulting, risk management and validation documentation, so that quality, compliance and operations move in the same direction.
Quality & Process Validation
We support companies and machine builders in managing compliance throughout the entire life cycle of products, plants, systems and processes, turning complex regulatory requirements into operational, documented activities.
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Validation Documentation
Drafting and management of the technical and validation documentation required throughout the entire life cycle of systems, plants and processes.
Learn more Validation Documentation -
GMP Compliance & Quality Assurance
Specialist consulting on quality, GMP compliance, risk management and preparation for audits and inspections.
Learn more GMP Compliance and Quality Assurance -
Commissioning & Qualification
Execution of and support for commissioning, testing and qualification activities for systems, plants and software.
Learn more Commissioning and Qualification
Who we work with
Companies in regulated industries
- Pharmaceutical
- Medical
- Cosmetics
- Food
Technology builders and suppliers
- Machines
- Plants
- Software
- Utilities
Our values
Health is a non-negotiable value.
Our work affects the health of people and animals. We are proud of it, and we feel the weight of it: that is why every phase of validation is rigorously documented.