Carrying out qualification and validation of equipment and processes is essential to ensure quality and safety in various industries, such as Life Science and Medical Technology. But this can be a complex process, with a number of different steps that must be followed to meet the requirements set by regulations and standards.
As a quality assurance consultancy, we specialise in offering expert assistance in qualification and validation. We have a team of experienced consultants who have a deep technical understanding and knowledge of regulations and standards within the industry.
We can help you develop a qualification and validation plan based on your needs and requirements. Our team can help define and document requirements, conduct risk analysis and qualify equipment and processes according to relevant standards and regulations. We can also develop validation protocols and conduct validation tests to ensure that equipment and processes are working as they should and meet all requirements.
We can also help maintain a high standard of quality control and safety by developing and implementing training programs for staff in qualification and validation.
We have experience working with different types of equipment and processes in various industries, including life science and medical technology. We are also well versed in regulations and standards, such as the FDA’s 21 CFR Part 11 and the EU’s GMP.
Contact us today to discuss how we can help you ensure the quality and safety of your company’s equipment and processes through qualification and validation.