Validation Services Ensure Process Consistency

Synteract provides full and incremental validation services for clinical and safety data management systems. Our extensive product usage, industry experience and knowledge of regulatory requirements enable us to provide superior validation consulting services.

The most important goal is to document that a system consistently does what it is intended to do. Synteract provides full validation services including:

• Validation project management
• Validation requirements consulting
  
• Validation package development (Requirements, IQ/OQ/PQ, Traceability, Summary Report)
  
• Test script development
  
• Test script execution
• GAP analysis
  
• SOP development
  
• SOP review
  
• Post validation implementation services (Change Management)

SOP Development is Vital

Standard Operating Procedures (SOPs) are essential in the use of computerized systems for clinical research. Synteract can provide assistance and oversight in SOP development for you, leveraging our robust set of documented processes and industry experience. According to the FDA's Guidance for Industry: Computer Systems Used in Clinical Trials, SOPs should be established for, but not limited to:

• System setup/Installation
  
• Data collection and handling
  
• System validation
  
• System maintenance
  
• Data backup, recovery, and contingency plans
  
• Security
  
• Change control
  
• Quality assurance