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Validation
"We've used Biometrix to perform initial validation and re-validation of some of our most critical equipment since 2003. Their protocols are thorough, yet not excessive. Their validation engineers are a pleasure to work with and are always available to answer questions and provide guidance. Working with Biometrix is a respite of smooth sailing – in an environment that is demanding and often changing."

- Validation Manager for pharmaceutical company

Biometrix Corporation provides high-quality validation services to the pharmaceutical, biotechnology and medical device industries of North America. Our services and products include:

Document Development: Biometrix has extensive experience in the development of high quality validation documentation. Years of accumulated experience in the validation industry give Biometrix a competitive edge at being able to quickly develop validation documentation that meets the specific needs of our clients. Biometrix can provide our clients with high-level guidance documents such as a Validation Master Plan, and we can provide validation protocols such as Installation Qualifications, Operational Qualifications and Performance Qualifications. We also provide specification documents such as Design Specifications, Functional Specifications and User Requirement Specifications.

Onsite Protocol Execution: Whether it's executing a client protocol or executing a protocol that has been custom-developed by Biometrix, Biometrix Validation Engineers can provide quality on-site protocol execution services. Our Validation Engineers are trained in proper GMP documentation practices, deviation management and change control procedures. Additionally, they understand the importance of following our clients' SOP's. We follow written procedures documented in approved protocols and adhere to strict GMP documentation practices in order to provide an accurate and complete validation documentation package.

Autoclave Cycle Development: Uncertain about how to configure your autoclave cycles and loads? Biometrix has extensive autoclave validation experience and can provide consulting services to assist our clients with the often difficult task of developing autoclave cycles and load configuration for validation. Biometrix can develop Cycle Development Protocols that meet our clients' specific requirements and can provide the necessary on-site assistance in executing the protocol.

Validation Staffing: Biometrix can provide our clients with the right validation professional to help you manage your fluctuating validation requirements. Biometrix Validation Engineers can be used to augment your staff during shutdowns, for project work, facility built-outs or if an employee suddenly leaves the company.