Technical

Project Planning

  • Feasibility Studies
  • Conceptual Design
  • Process Descriptions
  • Supplier Audits

Project Execution

  • Validation Plans
  • User Requirement Specifications/Briefs
  • New Equipment and Process Facilities
  • Equipment and Process Upgrades
  • Design Review (inc. 21CFR part 11 assessments)
  • Risk and Impact Assessments
  • Commissioning
  • Qualification (IQ/OQ/PQ)
  • Validation (Cleaning/Sterilisation/Process)

Production Support

  • Fault Finding and Correction
  • Change Control
  • Deviation Reports
  • SOP writing
  • Calibration Routines
  • Maintenance Routines
  • Revalidation
PEC (Denmark) A/S - Telephone +45 23 32 43 78 - Mail info@pec.dk
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