Validation and Documentation

Decades of Experience. Modular Approach.

Compliant Systems you can count on.

Validation

Decades of experience building machinery for the medical, pharmaceutical, and contract converters means that we can provide you with what you need to get your team ready for production. We are committed to delivering high quality systems enabling our customers to comply with 21 CFR Part 11 and efficiently complete the validation of their machines. Our validation practices are modeled after GAMP and allow the flexibility to work with you and your project needs. We will work with you throughout the development of your machine to provide design risk analysis, functional/design specifications, IQ/OQ testing documentation, onsite testing and more.

Custom Documentation

Just like our machines, our documentation is modular. This allows us to easily provide custom procedures, validation documents and custom training for each machine build. Modular test procedures for validation and acceptance gives us the time to focus on the new or critical areas of each project. We can work with you make your install-to-production time quick and efficient. Let us provide you with the resources needed to keep your team on track.

On Site Capabilities

In addition to our production converting and lab equipment, we have a Laser test lab, Class 10,000 Clean-room, Optical Comparators, High-speed camera’s, Peel Tester and a variety of other resources onsite to help aid you in the development and validation of your products and processes.