Validation

NJM offers complete FDA or GAMP5 validation and compliance assistance to customers for an individual machine or an entire line. The qualification services offered include:

• Design Specifications Development (URS, FDS, HDS, SDS, etc.)
• IQOQ / PQ Protocols Generation and Implementation
• SOP Development and Review
• FAT / SAT Protocols Generation and Implementation

Working with experienced validation professionals, NJM uses an efficient, systematic approach to documentation in order to prepare qualification protocols while the equipment is being designed and assembled. Protocols are submitted for review and approval prior to equipment delivery. NJM employs a very pragmatic approach to protocol execution in order to fulfill all regulatory documentation requirements quickly and efficiently thus enabling customers to begin using equipment for production in the shortest time possible.

On-site implementation services are also offered by NJM.