Our Refrigerator Validation Services Include:
- Protocols aimed at robust compliance
- Use of NIST-traceable Kaye Validators and three-point premium sensor calibration prior to qualification activities and verification after qualification is complete
- Empty & full chamber mapping to assess temperature distribution
- Power loss recovery test and open door recovery studies
- An audit-ready final document package
Biometrix can validate your refrigerator to the strictest of requirements, whether you are preparing for an FDA audit, or complying with 21 CFR Part 211 or ISO-13485
Each of our Validation Engineers has over ten years of field-service experience in executing FDA-compliant protocols, coupled with extensive training in current Good Manufacturing Practices (cGMP) and safety protocols
Our Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols reflect a customized approach aimed at delivering robust and efficient regulatory compliance coupled with the desired degree of confidence.
We include our clients in the review, edit and approval cycles of all testing protocols.
An array of high-performance premium calibrated thermocouples are used to qualify the operation and performance of your refrigerator. All test equipment is calibrated to NIST-traceable standards before and after your validation to ensure the utmost accuracy.
Your audit-ready documentation package includes a summary report, completed protocol and detailed data with all requisite statistical calculations and attachments including calibration certificates.
Our competitive pricing reflects our many years of experience coupled with our extensive library of hundreds of executed protocols, which we reference to expedite new document packages. This time-savings approach is gladly passed on to you as lower pricing. We also structure our hours on-site to not interfere with your peak activity periods, thus minimizing equipment down-time.
Let's get started today! A quick call to our toll-free number 1-800-890-8909 will reach one of our experienced engineers with informative answers to your questions and same-day pricing (24 hours or less).
We look forward to being of service!
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