• Training on methods and procedures available
• Advice on appropriate methods for your product
• Development of protocols and test plans

Risk Assessment

• Training on risk assessment; Failure Mode and Effects Analysis (FMEA), Hazard Analysis (HACCP), and other methods
• Perform risk assessments for laboratory, manufacturing and quality operations
• Set up risk assessment programs and procedures

Computerized Systems

• Review of facility and system design for automated manufacturing processes
• Design of validation, procedures
• Audit of process control and equipment computer-related systems
• Review of control systems for laboratory equipment
• Development of validation master plans
• Change control and change management procedures development, review or assessment