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Document ID: Doc11-Ver1-Issue1 Document type: Document

Title: DESIGN QUALIFICATION

Title: DESIGN QUALIFICATION

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

Authorized by: Date of Authorization

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Document ID: Doc11-Ver1-Issue1 Document type: Document

Title: DESIGN QUALIFICATION

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

DESIGN QUALIFICATION PROCESS Description of the intended purpose and analysis

2.2

Selection of the analysis technique

2.3

Selection of equipment and suppliers

The following equipment and suppliers have been preliminary selected:

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:

Equipment 1 is controlled by the following software: Name and version: Manufacturer/Brand: Technical specifications:

2.3.2 Equipment 2

2.3.3 Equipment 3

2.3.4 Equipment 4

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Page 3 of 4

Document ID: Doc11-Ver1-Issue1 Document type: Document

Title: DESIGN QUALIFICATION

2.4

Comparison of selected equipment and supplier

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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Page 4 of 4

Document ID: Doc11-Ver1-Issue1 Document type: Document

Title: DESIGN QUALIFICATION Impact on budget: Executive summary:

2.5

Final selection of equipment and supplier

CONCLUSION

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