Support as quality assurance

As part of its plant expansion, the client had a temporary need for manpower to support its quality assurance group to process all documents related to the project and minimize negative impact on its routine operations.

Genipro was mandated to provide an experienced resource with a QA profile to act as a final reviewer and approver of validation documents.

Thanks to an experienced Genipro resource, we were able to handle the review and approval of the documents. In order to allow the conditional release of the various systems, we recommended amending the change control procedure to allow the partial release of the utility systems and thus continue the qualification of the equipment in the new plant even if the validation activities were not all completed. The client was able to maintain its focus on its routine activities during the start-up of the expansion plant and thus continue to supply the market with its pharmaceutical products.