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Computer System Lifecycle Support for Packaged Equipment System

Updated: Nov 29, 2020

Director of Computer Validation Services Michelle Vander Missen was contacted by a new bio-process manufacturing facility in the pharmaceutical industry. The company had a new piece of automated packaged processing equipment but did not have the resources or staff in order to support its validation, and the timeline to get the job done was very short.


Vander Missen and Process Alliance offered assistance in the means of trained support staff that worked directly on-site with the facility’s engineering team. They investigated the necessary questions, such as:


· What is the right size package?

· What aligns with other equipment already being used at the facility?

· What might need to be updated for improvements and changes in standards since the last piece of automated package equipment had been installed in the facility?


A lot of work was done by Process Alliance in defining specific customer expectations, planning meetings, and using various forms of communication in order to ensure a satisfactory delivery. All of these helped move the facility staff quickly through approvals for the validation of the new packaging system.


While the project is ongoing and is not set to end until March 1, 2020 (update this case study), Vander Missen ensured that all documents were delivered and approved to the customer’s satisfaction before the projected timeline.


“We still have a few more to deliver,” said Vander Missen, “but everybody’s been just thrilled so far with how quickly we’ve been able to deliver things.”

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