System qualification

Equipment & System Division

Equipment and systems to ensure a full compliance

DOC team has an in-depth, hands-on personal experience in qualifying pharmaceutical equipment and systems to ensure full compliance to companies that are regulated by FDA, EMA or other Agencies. Our qualification activities incorporate ISPE Baseline Guide approach and the “make-right” job attitude in order to verify any system’s critical aspect.

Qualification and Validation Consultancy services include:

  • User Requirement Specification (URS) Preparation
  • Functional & Design Specification Revision (FDS)
  • 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

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