Validation Matters, Inc.

• Engineering design and qualification,
• Validation Master Planning/Execution
• Laboratory Analyitical Methods Validation
• QC/QA Compliance Auditing, including mock PAI by our former FDA agent
• cGMP, Equipment and Process training
• Batch Folder and Data Reviews

• Class 100 clean-room and BL-3 experience including gowning qualifications.
• Providing protocol generation, execution and final reporting (Commissioning, IQ, OQ, and PQ protocols), for facility expansion and equipment installations for classical pharmaceutical manufacturers, BL-3 facilities, including fermentators.
  
• Computer Systems Validations (CSV).
• Planning and development of Facility Master Plans, Validation Master Plans, including FAT/SAT support.
  
• CAPA’s following FDA 483’s and consent decrees.
• Utility systems including: Pure Air, Compressed Air, Nitrogen, and WFI.
• Auditing of supplier and contract manufacturers for cGMP.
• Equipment:  ICOS^®, Steris Amsco^®, Fedegari^®, Bellimed^®, Revco^® and Steriline^®. 
  
• Lab equipment: HPLC’s, Freezers, Refrigerators, Incubators and Milli-Q’s

Our experienced team can do it for you!!!