Quality System Development

 

PharmTech project managed a quality system implementation of a software update on a medical device production line consisting of 25 pieces of automated equipment.  This project had unique challenges because the client was rolling out a new quality system on a new automated production line for a new product across two continents. 


Collaboration included:

 

  1. Development of the quality system templates and golden examples to be used across the systems
  2. Training of validation personnel at two sites.
  3. Management responsibilities included schedule management, budget oversight, and coordinating resources as it related to the validation/qualification activities.
  4. Functional coordination was required between Software Development, Equipment Engineering, Quality, and Manufacturing.
  5. Team responsibilities included resolving debug issues found during startup, commissioning/dry runs of the system, and completing validation activities.