Quality Assurance and Compliance:
BioSRL’s quality assurance (QA) team ensures adherence to regulations, throughout all stages of clinical development. In addition, all offered clinical and bioanalytical services comply with GCP, GLP, and International Conference on Harmonisation (ICH) GCP guidelines.
As part of the company’s commitment to continuous improvement, BioSRLmeasures, assesses, and reports quality data, which is monitored to maintain performance. The corrective and preventive action (CAPA) process investigates out-of-specification events, deviations, and discrepancies to allow the implementation and documentation of corrective actions.
Maintenance is also a key area of focus for BioSRL, ensuring operational equipment is appropriately maintained.
QA services include:
– Clinical and analytical laboratories
– Ethical committee
– Suppliers / vendor
– Computer systems
– Study deliverables
– Case report form (CRF)
– Clinical study reports
– Tables and listings
– Regulatory inspection preparedness
– Provide training to staffs for regulatory inspections
– Assist preparing responses to inspection findings
– Conduct mock regulatory inspections