Validation Services

CyberVal utilizes a risk based approach for targeting the validation effort. Based on well defined user requirements and regulatory guidelines, a risk model is developed to document and identify critical path processes.

Our Professional Consultants specialize in unique validation situations that require partial or full revalidation efforts for system upgrades, moving laboratories, new laboratories, and computerized systems. The documentation that is written is based on current industry best practices and standards. Templates are utilized to accelerate the documentation development review and approval processes.

Following internal specific change control procedures, CyberVal adopts a cohesive approach for working within an organizations unique framework, conventions for validation deliverables, and document format expectations.

• Risk Analysis model
• Regulatory interpretation document
• Vendor selection and auditing report
• Master Plan document
• Design / Configuration document
• User Requirements Specification
• Functional Requirements Specification
• Testing protocols
• Qualifications
• Process Analytical Technologies
• Production processes
• In-line or near-line analyzers
• Traceability Matrix
• Summary Reports