Usually validation projects encompass re-validations of many older products that need to be upgraded to todays’ standard and / or few new products that need to be prepared for launch. MVLSC risk assesses the situation, produces the concept (e.g. Master Validation Plan, Guideline etc.) and a scalable project plan with cost estimate for the remediation of the gaps. After the management approval of the plan or parts of it, MVLSC sets up the validation team and helps with the first validations. After that the internal validation team is able to perform the rest of the project on their own, or if the customer wishes, a MVLSC team can perform the work.
If you are interested in the concept in detail, get the white paper by means of the form on this page.
If you want to know about our customer’s experience with the concept, please read the references.