QUALIFICATION & VALIDATION

-: Greetings from Parsan Engineers & Consultants :-

QUALIFICATION & VALIDATION



1. Preparation of Site Master File.

2. Creating Quality Manual Documents.

3. Computer System Validation

4. Creating process- describing methods “Standard Operation Procedure” (SOP)

5. OEL level validation

6. Preparation of Validation documents includes:

  • User Requirements Specifications (URS)
  • Detail Design Specifications (DDS)
  • Master Validation Plan
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Change Control / Deviation
  • Risk Assessment
  • Validation SOPs
  • Execution of Validation Protocols and resolution of deviations

7. Preparation of Validation Protocols and relevant SOPs for:

  • Process Validation
  • Cleaning Validation
  • Validation of Computer system and PLC
  • Validation of analytical methods with proven templates and check lists.
  • Validation of Equipments & Utilities with proven templates and check lists.

8. Prepare Calibration protocols for measuring equipments

  • Preparation of Calibration Schedule, equipment log book, status tags and room clearance checklists
  • Personnel training protocols in the issues of “Good Manufacturing Practice”.
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