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Validation mandate in a staff loan mode




Montreal area (Quebec), Canada


Qualification and validation


Struggling with a major project, our client's validation team needed support during a period of high workload.


Genipro's services were retained to transfer knowledge and provide coaching to junior members of the client's validation team. Our mandate also aimed to contribute to the day-to-day activities of the validation group to reduce the backlog in regulated activities such as the implementation of various changes related to manufacturing and packaging equipment as well as the requalification of equipment and the writing of several validation documents based on a risk-based approach.


Given the high level of activity and the accumulated backlog prior to our arrival, we had to adapt and take over quickly a major project to validate a new cartoning machine as well as the implementation of several changes on a packaging line. Several protocols had to be written and executed within a few weeks while supporting the client's engineering team as a validation expert for the commissioning of several line equipment following their relocation to allow the installation of the new cartoner. The project was carried out according to a tight schedule which was successfully met, and the new packaging equipment was released for use within the deadlines established with the client. Our coaching mandate was carried out by our experienced resource assigned to this mandate who involved designated members of the client's validation team, throughout the project and in various scenarios. Coaching and support allowed them to learn to recognize and avoid potential problems as well as to find simple, effective solutions that meet regulatory requirements.
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