Pharmaceutical and medical device manufacturing facilities among the most complex industrial buildings, creating some of our most personal, sensitive and important products. Each building contains numerous pieces of integrated equipment, highly controlled support and utility systems, and regulated monitoring and documentation requirements. Add in that there are typically numerous environmental testing contractors who each produce reporting forms in varying levels of detail, sophistication, and formats. When engaged in construction and equipment integration for new facilities, this complexity often leaves QA and validation teams sifting through volumes of extraneous information in written and digital form, and struggling for clarity. Even after a new facility is validated, the challenge can be exacerbated when new contractors are engaged in the continuing monitoring and reporting, again introducing unique forms, processes, and formats.
AMA is sensitive to these challenges, and has a proven history of working closely with all parties including the client QA and validation teams, to initiate a plan and protocols to direct and orchestrate all the activities and deliverables. The process ensures that test activities are focused, the proper data is recorded, and it’s presented in a clear and concise manner. This customized approach ultimately leads to a more efficient and productive workflow for everyone involved, translating into an expedited schedule, clearest scope, and ultimately lowest cost.