Quality Management Systems (QMS) for life science companies

The QMS is not only a collection of required Standard Operating Procedures (SOPs). It should offer you support for structuring and standardisation of critical activities such as supplier management, documentation management, company organisation, training, inspections and operations.

The QMS will also provide you with useful tools such as risk assessment and change management, or CAPA system that can save time and resources by doing the right thing at the right time.

Depending on your company, different regulations may be applicable such as the EudraLex volume 4 – GMP guidelines, the EU Good Distribution Practice of medicinal products for human use, Good Laboratory Practices or ISO-standards.

As a Marketing Authorisation Holder you will find that your QMS needs to include parts from different regulations. Keeping focus on your specific business and organisation is critical to achieve a system that gives efficient support.