Validation Plan Development
Commissioning & Qualification
As part of a facility expansion in Denmark, a global biotechnology manufacturer needed to ensure all commissioning, qualification and validation services were performed properly and on time. Due to our client’s limited in-house expertise and time sensitivity related to the expansion schedule, Oxford was engaged to supply senior-level experts who possessed the required skill sets.
Over a period of four years, we provided several teams of consultants to support both project expansions and operational work. Tasks included writing and executing qualification and validation protocols for cleaning, temperature mapping, sterilization, autoclaves, and glass washers. During the course of the project, an Oxford Account Manager developed a strong relationship with our client to ensure services and expectations were met consistently.
Our client successfully completed their expansion and met deadlines as needed. This led to additional project requests, including services in the areas of Project Management, Risk Management, Planning and Scheduling, Automation, QMS Implementation, as well as CQV. We’ve continued to support our client in three different locations, including a new state-of-the-art manufacturing facility in central Europe.