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ANNEXURES

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Equipment Qualification/Requalification schedule
Document No : --------------
Department : -------------
Section : --------------
Effective Date : ------------
Sr. No.
Name of
Equipment
Equipment ID.
No.
Initial
Qualification
Date
Qualification/
Requalification
Done On
Periodic Requalification
due on
Requalification
Completion
Date
Next ReQualification
Due on
Checked By
(Sign./Date)
Remarks
Format for preparation of qualification documents (specimen copy)
QUALIFICATION DOCUMENT OF --------------------------------Department
Location
Name of the equipment
Equipment ID
Make
Model/type
Effective date(post approval)
Document & rev. No.
Effective date (pre- approval)
Reason for revision
TABLE OF CONTENTS
Sr. No.
1
2
3
Content
Page No.
Site acceptance test format
Sr.
No
1
2
3
4
4
5
Job Description
Status
Observation
if any
Remarks
Dimensions as per drawing
MOC certificate of product
Surface finish certificate if applicable
Motor, gear box or other parts should be of
stand make
Service manuals along with control drawings
are provided
Others
Recommendation format
Recommendation for…………………………………..
Ref. Protocol No. & Revision No.:
Effective Date:
Report No. & Revision No.:
Effective date:
Batch size:
Recommendation:
Addendum to Validation document format.
Addendum to ……. .…….
Addendum No.:
Effective Date :
Initial Document Name:
Initial Document No:
Effective Date of Initial Document:
Description of Supplement
Qualification document numbering log
Sr.
Equipment
Equipment
URS
DQ
IQ
OQ
PQ
Updated by
Checked by
Remark
No.
Name
ID
No.
No.
No.
No.
No.
(Sign./Date)
(Sign./Date)
1
2
3
Release of Equipment
Release of Equipment/System for Routine Activity
This is to certify that…………………………….
Name of the Equipment/System:
Equipment ID:
Make:
Model:
Has been Installed, Commissioned, and Qualified in …………area having room ID …… and
same has proven satisfactory.
Thereby, the Equipment/ System is handover to the user department on
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