Design Qualification Template 4z4ey
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Page 1 of 4
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
INTRODUCTION..................................................................................................2
2
DESIGN QUALIFICATION PROCESS................................................................2
3
CONCLUSION .....................................................................................................4
Signatures: Signature
Date
Written by: Reviewed and Checked by: QA approved by:
Authorized by: Date of Authorization
Copyright © 2002 - 2005 labmetrology.com
labmetrology.com
Page 2 of 4
Document ID: Doc11-Ver1-Issue1 Document type: Document
Title: DESIGN QUALIFICATION
1
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
DESIGN QUALIFICATION PROCESS
2.1
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
Copyright © 2002 - 2005 labmetrology.com
labmetrology.com
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:
Copyright © 2002 - 2005 labmetrology.com
labmetrology.com
Page 4 of 4
Document ID: Doc11-Ver1-Issue1 Document type: Document
Title: DESIGN QUALIFICATION Impact on budget: Executive summary:
2.5
3
Final selection of equipment and supplier
CONCLUSION
Copyright © 2002 - 2005 labmetrology.com
Page 1 of 4
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
INTRODUCTION..................................................................................................2
2
DESIGN QUALIFICATION PROCESS................................................................2
3
CONCLUSION .....................................................................................................4
Signatures: Signature
Date
Written by: Reviewed and Checked by: QA approved by:
Authorized by: Date of Authorization
Copyright © 2002 - 2005 labmetrology.com
labmetrology.com
Page 2 of 4
Document ID: Doc11-Ver1-Issue1 Document type: Document
Title: DESIGN QUALIFICATION
1
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
DESIGN QUALIFICATION PROCESS
2.1
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
Copyright © 2002 - 2005 labmetrology.com
labmetrology.com
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:
Copyright © 2002 - 2005 labmetrology.com
labmetrology.com
Page 4 of 4
Document ID: Doc11-Ver1-Issue1 Document type: Document
Title: DESIGN QUALIFICATION Impact on budget: Executive summary:
2.5
3
Final selection of equipment and supplier
CONCLUSION
Copyright © 2002 - 2005 labmetrology.com
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