Qualification & Validation
Having an integrated concept right from the start of your project is an important requirement for GMP compliance and efficient qualification & validation. This is the only way to save costs, resources and time and also implement statutory requirements pro-actively. We develop comprehensive qualification and validation concepts early-on in the planning phase in order to minimize your project risks.
We are familiar with the requirements of the life science industry and can support you with the qualification and validation of your systems and processes. Regardless of whether according to your specifications or to our proven standards – we will implement all qualification activities for your project according to a unified system: starting with the creation of Qualification and Validation Master Plans (QMP, VMP) to Risk Analyses (RA) and qualification plans and reports for all stages of qualification (DQ, IQ, OQ, PQ). We verify qualification documents from suppliers according to your qualification specifications and implement GMP audits.
Our professionally trained qualification team with its vast international expertise is available to you for all quality assurance measures and GMP compliance activities.