Check List for New Equipment Qualification's

  Check List for New Equipment Qualification's
  Sr. No List of Documents and activities Date Remarks (Reason for Not applicable)
  1 URS    
  2 Vendor DQ    
  3 PO    
  4  FAT SAT & DQ report    
  5 Risk Assessment     
  6 Risk Assessment ID Allotment and Approval     
  7 Change Control initiation date with CCR No.    
  8 Change Control  approved Date    
  9 Civil Works for Equipment Movement    
  10 Impacted AHU's Re-validations     
  11 Facility Qualification & Layouts     
  12 ID Request & Number Allotment Confirmation    
  13 IQ Protocol     
  14 IQ Report (Major component certification)    
  15 OQ Protocol     
  16 Calibration of Instruments     
  17 New SOP Number Request & Conformation     
  18 Operatoin, Cleaning and PM SOP's Effective & Master     
  19 OQ Report (Sequentional, Fumctional & Alarms)    
  20 Formats issuence (ACR, ECR & Log books)    
  21 PM and Calibration Calenders approval and Issueance    
  22 PQ Protocol     
  23 PQ Execution Data Compilation    
  24 Report preparation if annexures should be filling    
  25 Report Approval Released to Usage     
  26 Filing with Labling and Sent to Archival