Lab Qualification at major pharma site
The Quality Control department of one of our clients, active in the production of innovative biological medicines and vaccines, was looking for a reliable partner for the outsourcing of its Equipment Lifecycle Management (ELM), with a focus on Lab Equipment Qualification. In addition to the pilot project at a major Dutch site, Agidens ensured the program could be rolled out internationally.
Since many years, Agidens successfully provides Lab Instrument Qualification Services at several sites of our client. The Agidens consultants are no strangers to the location where we implemented the lab equipment qualification either. A team of consultants already support the Technical Operations and the Engineering Department with validation and qualification expertise.
To work as efficient as possible and to streamline the processes, an organizational structure with a SPOC on both sides was put in place. The set-up ensures Qualification knowledge and documents are fully leveraged across the different sites.
The initial scope comprised of the introduction, replacement or decommissioning of CSV, non-CSV and calibration-only. It ranges from simple basic equipment such as plateshakers till complex qPCR systems.
“Agidens is a specialized player in a niche market. Having successfully completed projects together in the past, our customer knew what solid knowledge they were getting by partnering with us.”
“For this pilot, we set up a team of six consultants, well balanced between junior, medior and senior engineers. Our competence in Laboratory Equipment Validation and excellent track record at other plants, open communication, teamwork, sharing knowledge across the different sites and willingness to scale up regionally and globally, contributed to a satisfied customer.”