Our services in Quality Assurance
Quality management
system
Creating a quality system that meets regulations and standards is relatively easy. However, to succeed in developing a quality system that is both compliant and adapted to your business, which becomes a support instead of an obstacle, is anything but trivial. With the right skills and support, both implementation and, above all, usability will be optimal.
Release
Whether for Pharma, Medtech or other GxP-regulated products, we ensure that the release is safe, traceable and properly documented. The service is tailored to your needs, from temporary support during work peaks to longer-term QA assignments.
Non-conformity management
Managing non-conformities is crucial to maintaining systematic quality work. By identifying recurring patterns and root causes, you can prevent major errors before they have consequences. We help you with a clear and consistent approach that makes the process of capturing, investigating and following up on non-conformities as smooth as possible.
Risk management
Risk management is one of the cornerstones of quality assurance, whether in development, manufacturing or change management. We offer operational and strategic support in risk management within both GxP and ISO 14971. Everything from early development to finished product, from process to change management.
Audits and reviews
Audits are a requirement and a tool to build resilience and improve your business. Whether it's internal audits, supplier audits or preparation for regulatory inspections, we provide methodology, industry insight and the right depth and expertise in regulations such as GxP, MDR, IVDR, CFR, MDSAP and others.
Project QA
One of the cornerstones of successful projects is to have a QA with the right skills and understanding of both business requirements and conditions. Our experienced QA can support you in several different projects - with deep expertise, broad experience of different types of businesses and a sensitivity to the organization, they will be an addition to your delivery.
Our Compliance Partner service gives you access to the expertise you need most, in the right Location, at the right time.
Projects that really deliver on next level level change management from start to finish.
With our Academy, we offer relevant and Customised courses that meet both today's and tomorrow's needs in Life Science.
