Validation

COMPLIANCE ASSURED AND INSURED

Achieve a new level of confidence with Vital's comprehensive validation support for all your pharmaceutical development needs. Our experienced staff will ensure you meet full compliance with all required regulatory requirements. Vital's Validation Services assures you receive the highest quality service conducted with the strictest confidentiality.

Vital Therapeutics with its operational experience, provides a full range of Validation Services based on Standard Operating Procedures and Re-Qualification and Change Control Programs. These services include Facilities and Equipment Qualification, Process and Cleaning Validation, Method Validation, Laboratory Instrument and Manufacturing Equipment Qualification all in full compliance with applicable regulatory requirements. Our extensive supply of test equipment used in validation studies is calibrated and maintained according to a strict automated schedule and NIST traceable standards.

The Validations Group is dedicated to providing a cost-effective validation strategy while providing the highest quality work and maintaining strict confidentiality.

We offer

• A Validation Master Plan
  
• Project Management
  
• Installation, Operational, and Performance Qualification
  
• Protocol Execution
  
• Process, Cleaning, and Design Validation
  
• Critical Utility Qualification
• Standard Operating Procedures (SOP) Development and Implementation
  
• Investigative Support
  
• Final Report Development
  
• Representation and Defense of Studies to the Regulatory Authorities
  
• Factory compliance Testing
  
• Plant and site acceptance testing (PAT, SAT)
  
• Laboratory Equipment Validation