System Qualification

Equipment and system qualification to ensure a full compilance. 

 

At DOC, our team has in-depth, hands-on experience in the qualification of pharmaceutical equipment and systems, ensuring companies that are regulated by FDA, EMA or other agencies comply with agency expectations. Our qualification methods involve an ISPE Baseline Guide approach, along with a 'get it sorted' attitude to verify any system's critical aspect.

 

Qualification and Validation Consultancy services include: 

 

  • User Requirement Specification (URS) preparation 
  • Functions & Design Specification revision (FDSI) 
  • Quality Risk Management (QRM) 
  • Traceability Matrix 
  • Validation Master Plan 
  • Design Qualification and Enhanced Design Review 
  • Qualification protocols writing and execution for installation, Operational and Performance Qualification 
  • Change Control Assessment 
  • Standard Operation Procedures (SOP) development

For more information, please contact:

Manfredi