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Comment: Enter the intended purpose of the design qualification in the title for
clarity.
1 2 3
INTRODUCTION.......................................................................
...........................2 DESIGN QUALIFICATION
PROCESS................................................................2 CONCLUSION
...................................................................................
..................4
Signatures: Signature Written by: Reviewed and Checked by: QA approved by: Date
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INTRODUCTION
Design qualification is the documented verification that the proposed design of the
equipment or systems to be qualified is suitable for the intended purpose.
2 2.1
2.2
2.3
2.3.1 Equipment 1
Equipment 1 is composed of the following instruments: • Instrument 1 name: •
Manufacturer/Brand: • Technical specifications: • Health & safety requirements: • •
• • Instrument 2 name: Manufacturer/Brand: Technical specifications: Health &
safety requirements:
2.3.2 Equipment 2
2.3.3 Equipment 3
2.3.4 Equipment 4
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2.4
2.4.1 Equipment 1
Advantages: Drawbacks: Impact on budget: Executive summary:
2.4.2 Equipment 2
Advantages: Drawbacks: Impact on budget: Executive summary:
2.4.3 Equipment 3
Advantages: Drawbacks: Impact on budget: Executive summary:
2.4.4 Equipment 4
Advantages: Drawbacks:
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2.5
CONCLUSION