Case Study: Resources for Validation/Commissioning project


A large facility of a global pharmaceutical client received a Warning Letter which required the site to revalidate a significant portion of the manufacturing equipment.  


We deployed a Program Manager and a small number of Project Managers to organize and execute the equipment and process revalidation activities for the close to one-hundred pieces of equipment included in the Warning Letter.  

  • Our team developed detailed plans for each revalidation project.
  • We developed an aggressive timeline and staffing plans.
  • We supplemented the client resources with multiple validation teams to ensure the aggressive timeline was met.
  • We bridged capability gaps on multiple client teams.

  • The client completed the revalidation commitments three months ahead of schedule.

Project Examples

  1. For a medical device client, an SME supported the validation of all utilities for a plant expansion.
  2. For a biologics client, a small team validated multiple new autoclaves.
  3. For a pharmaceutical client, a small team validated multiple new packaging lines being deployed at the site.