What we do
At GMP4U, we provide a wide range of engineering and consulting services designed to support your business in the life sciences sector in Switzerland. Our primary focus is supporting our customers in achieving and maintaining GMP compliance for production equipment, laboratory equipment, computerized systems and information management systems.
Our solutions are tailored to meet your specific needs, whether you are a start-up or an established player.
Our solutions are tailored to meet your specific needs, whether you are a start-up or an established player.
New equipment or system
We guide you throughout the entire process of putting new equipment or systems into operation. This covers identifying the user’s needs, defining SMART requirements, supplier selection and audits, defining and implementing risk-based qualification and validation strategies, creating qualification and validation deliverables (URS, validation plan, design documents, risk analysis, traceability matrix, test plans, summary reports...), leading FAT/SAT activities, drafting work instructions and training of employees, hands-on execution of test plans, final release of equipment or system for GxP regulated use. With our dedicated support and experience, we ensures a smooth transition to daily operation.
Support during entire equipment or system life cycle
We support you in all phases of the equipment or system life cycle to ensure compliance with regulatory requirements and standards. We help you providing documented evidence showing that the equipment or system is fit for its intended use and that this status is maintained. We make sure that your operations meet the Good Manufacturing Practices (GMP) standards to guarantee compliance, product quality, data integrity and patient safety.
Continuous compliance
We assist you in maintaining the qualified or validated status of your equipment or systems throughout the entire lifecycle. Our services include managing any changes, potential CAPAs or Non-conformities, performing periodic reviews to ensure continued compliance, and conduct periodic requalification or revalidation. This proactive approach helps mitigate risk, ensures ongoing regulatory adherence, minimizes disruptions to your operation and being prepared for quality audits at any time.