A medical device company, developer and manufacturer of implantable class III medical devices, hired us to help in one of their cGMP facilities transfer. The project scope included the transfer of the manufacturing equipment and their related processes such as real-time control/manufacturing automation systems. Our team started the qualification process of newly designed ISO Class 7 cleanroom suite by performing the validation studies for the cleanroom (as built, at rest, and operational) as well as their related utilities, and rewriting and implementing the equipment re-qualification protocols (IQ/OQ/PQ) for equipment/processes as well as re-writing SOPs for three lines of manufacturing (37 pieces of equipment) and completing the technical summary reports.
As part of the project execution, there were numerous software platforms that required validation and testing as part of developing and executing system life cycle deliverables (URS, SRS, FRS, DDS, RTM, Unit Integration, User Acceptance testing, Delta V, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report) as per 21 CFR Part 11 and provided training and mentoring to the technical staff. Getting this project done on time was not only critical for the client to bring the entire transfer project back on schedule but to bring the product inventory level to a safe one as well.
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