QUALITY & VENDOR ASSURANCE

QUALITY ASSURANCE

Quality Assurance systems and processes play an integral role in all phases of product / device development, with compliant and accurate systems producing consistent data with high integrity.

Our Quality Assurance Department administers our Quality Management System(QMS) from our Sydney based head quarters. The scope of the QMS includes all areas of service provision. The QMS is designed to support clinical trial processes for both medicines and devices ensuring compliance with ICH E6 GCP and ISO 14155. The Quality Management System incorporates the core processes of document control, training, issue management, vendor qualification and management, system validation, internal quality reviews and risk assessment.

We welcome client qualification audits and have the capability to support audits in a variety of ways that are convenient for our clients.

VENDOR ASSURANCE

Using third party vendors to provide you with specialised services for your trial is a significant consideration. Whether it be analysing trial samples or providing a repository for your documentation, contracted services require appropriate qualification prior to use and management throughout the trial. Southern Star Research have a number of qualified vendors we can refer to our QA manager that can be contracted to assist you with your vendor selection, assessment and ongoing management.

Our QA staff are experienced professionals offering independent auditing services including:

  • Quality Management Systems
  • Third Party Vendor Audits and Management
    • Good Clinical Laboratory Practice (GCLP)
    • IP Distribution and Storage Facilities
    • Central Laboratories
    • Archive Facilities
    • Bio-repositories
    • Bio-analytical Laboratories
  • Good Clinical Practice (GCP) Audits
  • GLP (OECD Principles/21 CFR Part 58) Audits
  • Computerised System Audits
    • CTMS
    • eTMF
    • EDC