Qualification and validation

Qualification and validation are regulatory requirements as well as part of good business practices. Xendo covers the fields of product & process development, manufacturing and QA/QC. Our integrated approach ensures that the required qualification and validation status of your facilities, utilities, equipment, processes, analytical methods and products are met.

Scope of services qualification and validation

• Designing Validation Master Plans
• Executing VMP / hands-on validation support
• Hands-on qualification of facilities, utilities and equipment
• Process and product validation
• Cleaning validation
• Validation of automated systems (21CFRpart11, GAMP)
• Validation of analytical methods (compendial/ICH)
• Operator qualification (aseptic production techniques)
• Risk assessment and risk control
• Training