Quality Assurance (QA)

Quality Assurance

Quality Assurance (QA), an independent group within Biosite, is responsible for ensuring the quality of the work provided by Biosite, and that all work is conducted in compliance with applicable GCP guidelines, relevant regulatory requirements and applicable Standard Operating Procedures (SOPs).

QA Team is also responsible for the Biosite quality management system and conducts internal system and project audits as well as vendor audits to ensure that vendors work to the same quality standards.

The Biosite auditors have many years of clinical development experience and routinely conduct GCP, Medical Device, GVP, GLP and GMP audits.

CONTRACT AUDIT SERVICES
TFS QA also provides contract audit services for clients and these include:
  • Vendor audits
  • System audits (e.g., pharmacovigilance and data base)
  • Study audits
  • Investigator site audits
  • Trial Master File audits
  • Document audits (e.g., protocol and study report)
  • Pre-inspection audits
  • Writing, reviewing and updating SOPs
  • Developing, reviewing and updating Quality Management Systems

Our Locations

Bengaluru Office

#740, Second Floor, 14th Main, Police Station Road, Kumarswamy Layout, Stage 1, Bengaluru - 560078. (Karnataka) INDIA

Gurgaon Office

T 17/7, Second Floor, DLLF Phase 3, Gurgaon - 122010. (Haryana) INDIA

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