Client was still performing the serialization system implementation during the planned week for the validation activities. At this point, there were no Field Engineers left on site since they were not scheduled to complete the system implementation.
Ultimate Solutions validation resources, which were trained as Field Engineers as well, got authorization from the client to continue working on the serialization system implementation in order to avoid delays and later executed the validation protocols.
Client had resources with combine experience & knowledge, in both the technical & validation aspects. They ended up with resources that could provide a solution to work first on the systems & then execute the protocols in order to comply with the schedule.
“The use of these resources was invaluable to the completion of the IQ/OQ. Both resources were not only excellent from the validation perspective, but their knowledge of the system operations, screens, connectivity & expected behavior added a new degree of efficiency… “
Author: Arleen Figueroa, Validation Manager | Carlos Castro, Technology Manager