BioOutsource — cGMP compliant biotesting
Quality Expertise
Our Quality Specialists and Auditors ensure compliance and the highest quality throughout the entire process: from initially setting expectations at the Quality Agreement stage, throughout material receipt, testing, to the report / COA despatch and finally the archive stage.
- Preparation of Quality / Technical Agreements in conjunction with the client
- Receipt & Release of Client Test Material to the study
- Assure quality of raw materials
- Validation Compliance (Facility, Equipment, Systems, etc)
- Master Protocol and SOP audit / approval
- 'In-life' Study and laboratory Inspection programme
- Audit and compliance approval of study data and COA / Final Reports
- Monitoring & review of potential deviations, OOS, etc
- Host client and regulatory audits
- Perform inspections of client-specified subcontractors
- Perform Vendor inspections and maintain Vendor Assurance Programme
- Tracking / trending of key quality indicators
- Operational Excellence using Six Sigma and Lean methodologies
Additionally within the Quality department is a dedicated Site Document Controller. Document Control plays a crucial role for traceability and chain of custody within our Quality Systems.
- Controlled Master documents (e-docs and hard copy)
- Control and monitoring of document Issue and recall
- E-access control
- Upload of raw data for client access on the BioWeb
- Archiving
