Validation &
Qualification
Document your data
According to GAMP and our work with some of the biggest suppliers of pharmaceutical products in Denmark, ensure a high quality of trustworthy and easy-to-understand validation. We have in-house cloud-based solutions for paperless validation.
Validation
According to the latest trends in the market, we have expert knowledge in providing a risk-based approach to establishing a set of requirements and design documents to support your business needs and the transparency of the supplied solution.
We ensure that your system is in control and your business is ready for any inspection.
Qualification
Using a paperless validation method we supply access to our cloud-based HP ALM solution, an option for your business to utilize the latest cutting edge technology to store and access your validation documentation online in a protected and secure environment.
We have maintained large systems in this type of tool for a period of more than 5 years, we focus on standardization, and transparency of all your validated equipment!
Documentation
We are experts and have +15 years of experience working with the absolute largest pharmaceutical company in Denmark.
Following the GAMP5, and knowledge of regulatory bodies, we are the perfect fit to help you document your system.
From Impact assessing, Planning, and designing, through design qualification, to acceptance test followed by IQ, OQ, and PQ activities, we cover the entire v-model, and conclude in reports that get QA approval first time!