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:
Auditing
Clinical and analytical laboratories
Ethical committee
Suppliers / vendor
Validation
Computer systems
Databases
Study deliverables
Protocols
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