ALTEN supported QA operations in Canada by updating mixing validation protocols and new packaging systems. With documentation-heavy workflows and cross-team coordination, their engineers ensured each protocol passed smoothly from lab to line.
This case study details ALTEN Technology’s involvement in two critical Life Sciences/Pharma validation projects. One project focused on updating validation protocols for mixing procedures within QA Technical Services, while the other involved completing the validation of new manufacturing equipment, specifically a label machine for a plastic pour bottle production line, also for QA Technical Services. The work was predominantly documentation-heavy, accounting for 50% of the effort, encompassing the writing of process and cleaning validation protocols and the design of IQ/OQ validation campaigns. Execution comprised 30% of the work, involving the implementation of protocols and validation plans, alongside participation in investigations to identify root causes and preventative measures. The remaining 20% was dedicated to coordination, which included managing validation activities with production, lab teams, and outside contractors, monitoring protocol execution, and coordinating verifications of completed protocols with quality teams. A key procedural element was that documentation required initial approval from the quality team before validation and subsequent handover to the engineering team for execution. ALTEN Technology provided significant added value to these initiatives by leveraging its extensive life science expertise, drawn from a wide range of past and current pharmaceutical clients. The two-person team, operating on a Time & Material basis since March 2024 from Toronto, Canada, utilized key tools such as TrackWise, MS Office, and MS Project to successfully deliver these projects.