GAMP 5 ® (ISPE) is an accurate methodology to validate (automated) systems for companies in the life sciences industry. It is a structured and project based approach that can be tailored to each organisation. Wondering how to validate systems or applications on mobile devices or in the cloud or other questions regarding system validation? QbD has several validation consultants with extensive knowledge to help you apply the GAMP 5 guidelines at a strategic level.
Our GAMP 5 consultants are up to date on the latest insights and make use of a pragmatic, risk-based approach – based on their expertise and industry best practices. We always start with a risk analysis, to investigate risks and determine the most important functions for testing. This way, we work in the most efficient way possible and we help you focus on product quality and patient safety while reducing validation costs. Together, we tackle possible gaps to make your quality system more robust and audit-proof.
QbD offers consultants for various kinds of projects. We are able to guide your company during validation processes, or completely carry out your project from A to Z, including testing and writing documents like user requirements. If you are not sure if your system needs to be validated, we advise you on the best approach and working method. In short, we offer GAMP 5 consultants with the right experience and skills for short term and long term projects – internal or external. By playing an active and coaching role, we provide validated systems that satisfy every aspect of compliance.