Computerized System Validation
(Automation System, Laboratory System, Study Management System, Document Management System, etc.)

  • Sound validation plan optimizes workflow, resources and quality.
  • Adequate lifecycle documentation reduces record management effort and data discrepancy.
  • Logical qualification protocol assures effective and efficient testing fulfilling intended use.

Quality Assurance
(Documentation Management, Mock Audit, Data Integrity, etc.)

  • Simple and sensible document management enables lean documentation and ease of traceability.
  • Customized mock audit against SOPs and regulations delivering quantifiable outputs for action prioritization.
  • Practical site-specific approaches attaining effective and accelerated data integrity compliance.

Training
(CSV, Data Integrity for CSV, etc.)

  • Relevant real-life or trainee scenarios enabling knowledge retention.
  • Hands-on practice enforces critical thinking and concept application.

Other Supporting Services

  • Project Management, Sterilization Validation, Microbiological Testing, etc.