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VALIDATION DOCUMENT
Doc. No.
QC-QD-XX-XX
Effective Date:
DD..MM.YYYY
Review Date
DD..MM.YYYY
Page
Page 1 of 8
DESIGN QUALIFICATION
Name
Written By:
Authorized By:
Signatu
and da
Electronics Technician
Operations Manger
a) Ejaz Ahmed
b) Shams-Ul-Arifeen
Production manager
c)S.M. Azher
Operations Manager
e) Asadullah Khan
Dr.Ajmal Nasir
Director Technical
Approved By:
Designation
Reviewed By:
DQ
BF Biosciences Limited
VALIDATION DOCUMENT
Doc. No.
QC-QD-XX-XX
Effective Date:
DD..MM.YYYY
Review Date
DD..MM.YYYY
Page
Page 2 of 8
DESIGN QUALIFICATION
DQ
2.
3.
CORRECTING ENTRIES
If you need to make corrections on a form, use the procedures described below:
Draw a diagonal line, bottom left to upper right, through the miss
entered or incorrect information.
2.
3.
4.
BF Biosciences Limited
VALIDATION DOCUMENT
Doc. No.
QC-QD-XX-XX
Effective Date:
DD..MM.YYYY
Review Date
DD..MM.YYYY
Page
Page 3 of 8
DESIGN QUALIFICATION
DQ
Draw a diagonal line, bottom left to upper right, through the miss
entered or incorrect information.
2.
3.
4.
5.
6.
Draw a diagonal line, bottom left to upper right corner, through the
element that is not required.
2.
Write the letters NA [Not Applicable], your initials, and the date above
the line. Include comments above the line or on the form to document
the reason the element is not required.
3.
The performer and reviewer must sign and date all forms, as usual, even when part or
all of the form is marked NA.
NOTE: ALL ORIGINAL ENTRIES MUST REMAIN LEGIBLE AFTER ANY CORRECTIONS HAVE BEEN
MADE.
BF Biosciences Limited
VALIDATION DOCUMENT
Doc. No.
QC-QD-XX-XX
Effective Date:
DD..MM.YYYY
Review Date
DD..MM.YYYY
Page
Page 4 of 8
DESIGN QUALIFICATION
DQ
CAUTION
The following conditions require re-qualification;
When a Instrument modification has been completed, it affects the installation
qualification.
When the software or firmware has been upgraded or changed
When this Instrument is being removed from where it was originally installed.
BF Biosciences Limited
VALIDATION DOCUMENT
Doc. No.
QC-QD-XX-XX
Effective Date:
DD..MM.YYYY
Review Date
DD..MM.YYYY
Page
Page 5 of 8
DESIGN QUALIFICATION
DQ
TABLE OF CONTENT
Section
Description
Page No.
1.
General Description
2.
3.
Introduction
4.
Objective
5.
Scope
6.
Acceptance Criteria
7.
Procedure
Attachment
8.
BF Biosciences Limited
VALIDATION DOCUMENT
Doc. No.
QC-QD-XX-XX
Effective Date:
DD..MM.YYYY
Review Date
DD..MM.YYYY
Page
Page 6 of 8
DESIGN QUALIFICATION
DQ
Identifying requirements
Director Technical:-
BF Biosciences Limited
VALIDATION DOCUMENT
Doc. No.
QC-QD-XX-XX
Effective Date:
DD..MM.YYYY
Review Date
DD..MM.YYYY
Page
Page 7 of 8
DESIGN QUALIFICATION
Section 5.0
DQ
Equipment/Instrument/System Description:
Finish Goods Products Cold room Should be As per given below Detail:
7.1.2
Requirements of Quality
7.1.3
Requirements of Engineering
7.1.4
General requirements
7.2
Design Brief
The consultant / vendor/supplier will design/ provide the
equipment/instrument/system on the basis of URS and drawing / layout
provided and will submit the design for approval. Followings are the key steps
BF Biosciences Limited
VALIDATION DOCUMENT
Doc. No.
QC-QD-XX-XX
Effective Date:
DD..MM.YYYY
Review Date
DD..MM.YYYY
Page
Page 8 of 8
DESIGN QUALIFICATION
DQ
according to which the consultant/ supplier will submit the design / specs for
review and approval.
7.2.1
7.2.2
7.2.3
Description.
Specifications.
Drawing / layout.
8. Attachments:
Annex 1:
Annex 2:
Annex 3:
Annex 4:
Annex 5:
Annex 6:
Annex 7: