Quality Assurance and Compliance

 

LLX services and systems are governed by well defined SOPs, policies and are compliant with regulatory requirements such as ICH/GCP, FDA 21 CFR Part 11 and other customer specific standards.

The Quality Assurance (QA) team works independently to ensure compliance with the protocol, SOPs, and regulatory requirements as well as the integrity and validity of study data and programs for statistical outputs.

The QA team conducts various types of audits at multiple stages throughout  the clinical development process we support. This enables early detection of potential problems and allows for intervention and implementation of appropriate corrective/preventative action, when necessary.

The LLX Quality Assurance team provides:

  • Regulatory training, as applicable to LLX personnel 
  • Internal system audits of study-related systems and procedures
  • Hosting of Sponsor Audits and Regulatory Inspections of LLX offices
  • Standard Operating Procedure (SOP) oversight
  • Vendor Audits of service providers
  • Support for preparation for Regulatory Inspection