Quality Assurance

TFS Quality and Compliance (TFSQ&C), an independent group within TFS, is responsible for ensuring the quality of the work provided by TFS, and that all work is conducted in compliance with applicable GxP guidelines, relevant regulatory requirements and applicable Standard Operating Procedures (SOPs).

TFSQ&C is also responsible for the TFS 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 TFS 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 customers 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

Contract quality management system services

  • Risk management
  • Policies
  • SOPs
  • Working intructions
  • Guidelines
  • Training