• Design Specifications Development (URS, FRS, DDS, etc.)
• IQ / OQ / PQ Protocols Generation and Implementation
• SOP Development and Review
• FAT / SAT Protocols Generation and Implementation
  

Working with experienced validation professionals, IMA Nova® uses an efficient, systematic approach to documentation in order to prepare qualification protocols while the equipment is being designed and assembled. Protocols are routinely submitted for review and approval prior to equipment delivery.

IMA Nova® also 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.

The validation specialists who work with IMA Nova® have extensive technical ability. They have considerable experience with process and packaging equipment design and operation. They also possess in-depth knowledge of the regulatory requirements and their interpretation, and they are keenly aware of the cost burden of equipment qualification. This blend of experience is unique among validation service suppliers.