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.