- 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 a long history of commitment to quality, in the excellence of its services and in the manner in which it conduct its business. We maintain a global, comprehensive, and integrated Quality System based on regulatory requirements and industry best practices. Customer satisfaction, efficient processes, and regulatory compliance are integral parts of our Quality Policy:
Our Quality System is based on international and industry best practices and complies with:
- US Food and Drug Administration (FDA)
- US Drug Enforcement Agency (DEA)
- State pharmacy regulations
- ISO, MHRA, HTA (UK facilities)
Our comprehensive set of standard operating procedures (SOPs) is implemented across all our facilities, ensuring uniformity in all our practices. Our SOPs, as well as our 28 years of experience, ensure quality and adherence to client and regulatory requirements. We have a program of client audits as well as a comprehensive internal audit system to ensure compliance in all our operations.
In addition, we employ advanced, industry-leading tools to implement and monitor our operations, such as:
- TrackWise quality management software
- Blue Mountain Calibration Manager™ software
- Our proprietary sample inventory information management system
- Option to access Thermo Fisher’s Nautilus LIMS
- Automated temperature monitoring systems
These tools are validated according to 21 CFR Part 11 requirements.
Our Quality Policy requires that we continuously test and investigate processes and practices through our corrective actions and preventive actions (CAPA) Program, our practical process improvement (PPI) program, and others.