- Services Overview
- Biorepository/Biobanking Overview
- Cell Therapy Services
- Laboratory Overview
- Storage/Transport of Bio-API
- Kit Production/Clinical Trial Support
- Qualification / Validation Services
- News/Press Releases
Fisher BioServices has unmatched experience, people, technology, and equipment to validate the storage units and other equipment used in our biorepository and cold chain management operations.
We have been validating our internal and client owned equipment for more than 18 years. Our validation team ensures that all of our equipment meets and exceeds strict standards of quality.
Our protocols are designed and executed to ensure compliance with the US FDA requirements and guidance documents and according to quality standards established by the PDA (Parenteral Drug Association). All of our equipment and measuring devices are calibrated according to the NIST standards.
Our validation protocols, consisting of IQ (Installation Qualification), OQ (Operational Qualification), Performance Qualification (PQ), and final execution reports have been reviewed by the regulatory bodies around the world and during numerous client audits.