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.
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. Contact us for more information.
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.
You’ve read a lot about us, so now can we hear about you?
In the manufacture of any medical device or pharmaceutical product, validation and verification are two pivotal terms. We’ll break down the differences and use the production of a transdermal patch to provide examples of how they apply to the manufacturing process.Read more
Validation of your converting processes is critical, and GAMP is your guiding light. Developing your validation attributes requires focus on three critical areas, with a particular emphasis on the quality attributes that define your product.
Regardless of your feelings toward federal mandates, they often provoke changes within an industry. The new FDA mandate regarding UDIs (Unique Device Identifiers) will significantly change how medical device manufacturers approach product development, data integration, and contract manufacture.