Case Study

Validation of Semi-Automated Process for Serialization

Project Snapshot

A pharmaceutical company did not have the engineering nor program management technical resources needed to have their manual serialization process validated and qualified.

The client also needed support on preparations for performing validation/qualification of their semi-automated systems. The internal timeline was not aligned with what was needed to achieve desired results.

Project Size
4 Months
Project Management Team
3 Engineers
Chicago, IL

Project Challenges

  • An engineering solutions was needed to ensure the manual serialization process was validated and qualified
  • Sterling provided Project Management and Serialization expertise to specify, integrate and validate a vial and syringe serialization of the packaging operation per an aggressive timeline. SME’s were on the ground to project manage the equipment and tracking software system implementation. This project included validation and procedure development.  
  • Sterling developed a  streamlined communications protocol which has been utilized to support other fast track projects at the company. A direct line of communication was established with the client’s management team to conduct weekly updates, obtain resolution for all critical issues, and to enforce timely communication protocols within the entire team. A communication protocol was also established with all vendor suppliers and subcontractors to identify and address any and all technical issues in a timely fashion.
  • Once all documentation requirements were identified, a proactive timeline was established to position the entire team towards success.
  • Once the resources were in place, priorities were realigned, management buy in was achieved and timely communications were enforced amongst all on the team, the manual system was successfully validated/qualified per the timeline. Furthermore, the plan to achieve the same for the semi-automated system was put into place.
We used Sterling Engineering for several large strategic projects at plants across the country and I’ve been very pleased with their support. Their responsiveness to the demands of both internal and external stakeholders, their flexibility to changing priorities and scope of work, and their cross functional team approach contributed to project success.
R&D Pilot Plant Customer

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