Audit Services

Ensure Internal Compliance and That External Vendors Have Sufficient Capabilities

GBC provides internal and external auditing services.  GBC performs critical reviews of processes and associated documentation to provide results and analysis that help clients assess compliance levels and ensure applicable standards are met. GBC compliance and auditing services include:

General Auditing Services

• Preparation of Audit Plan
• Review and Organization of SOPs and QMS Documentation
• Review of Staff Training
• Review of Procedures
• Documentation of Observations and Deviations
• Preparation and Delivery of Audit Report
• Guidance for Resolution of Observations and Deviations

Internal Auditing

• Trial Master File (TMF) Audits (Clinical Studies)
• Data and Database Integrity Audits
• Inventory Audits (Investigational Materials, Biospecimens, Supplies, Equipment)
• Technical Process Audits
• Support for Certification Audit Preparedness

Clinical Site Auditing

• Sponsor Protocol Compliance
• Regulatory File and IRB Approval Audits
• Contractual Agreement Terms
• Internal Site Standard Operating Procedures (SOPs)
• Compliance with Sponsor Requirements
• Adverse Event (AE) Reporting

Lab and Vendor Auditing

• Organizational Structure and Personnel
• Ensuring Appropriate Experience and Resources
• Standard Operating Procedures (SOPs)
• Facilities and Equipment
• Equipment Monitoring, Maintenance and Calibration Records
• Data Collection and Handling Procedures

Click here for more information on the types of external organizations that GBC audits.

For additional information on GBC’s consulting services please contact consulting@globalbioclinical.com or register and send us your inquiry here.