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  • RDR-XXXXX Test Report Temp

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    Marianna Gofman
    24 views5 pages
    This 5-page document is a test report for an unnamed product. It details the document information, revision history, introduction, scope, purpose, definitions, referenced documents, responsibilities, test type and site, acceptance criteria, sample size and sampling plan, methods, materials and equipment, procedures, test records, results and analysis, revalidation, and list of appendixes. The document provides information on testing conducted for an unnamed medical device or product.

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    This 5-page document is a test report for an unnamed product. It details the document information, revision history, introduction, scope, purpose, definitions, referenced documents, responsibilities, test type and site, acceptance criteria, sample size and sampling plan, methods, materials and equipment, procedures, test records, results and analysis, revalidation, and list of appendixes. The document provides information on testing conducted for an unnamed medical device or product.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    24 views5 pages

    RDR-XXXXX Test Report Temp

    Uploaded by

    Marianna Gofman
    This 5-page document is a test report for an unnamed product. It details the document information, revision history, introduction, scope, purpose, definitions, referenced documents, responsibilities, test type and site, acceptance criteria, sample size and sampling plan, methods, materials and equipment, procedures, test records, results and analysis, revalidation, and list of appendixes. The document provides information on testing conducted for an unnamed medical device or product.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 5

    Verification & Validation RDR-XXXXX

    Document Name Test Report


    Month, 20YY Page 1 of 5 pages Revision 01

    Before Use - Verify that


    This is the Last Released revision of this Document

    Document Name Test Report

    Signature Date Title Name


    Written By
    Reviewed By
    Approved By

    Confidential
    Verification & Validation RDR-XXXXX
    Document Name Test Report
    Month, 20YY Page 2 of 5 pages Revision 01

    Revision History

    Revision Ref # Change Rationale & Description Date Signature


    01 - First Issue

    Confidential
    Verification & Validation RDR-XXXXX
    Document Name Test Report
    Month, 20YY Page 3 of 5 pages Revision 01

    1. Introduction
    1.1. ...

    2. Scope
    2.1. …

    3. Purpose
    3.1. ...

    4. Definitions
    4.1. …

    5. Referenced documents
    5.1. ...

    6. Responsibility
    6.1. …

    7. Test type, environment and site


    7.1. ...

    8. Acceptance criteria
    8.1. …

    9. Sample size / sampling plan


    9.1. …

    10. Method
    10.1. ...
    10.1.1.

    Confidential
    Verification & Validation RDR-XXXXX
    Document Name Test Report
    Month, 20YY Page 4 of 5 pages Revision 01

    11. Materials & equipment


    11.1. …

    12. Procedure
    12.1. …

    13. Test records


    The following test records shall be maintained and retained as part of the DHF:
    13.1. All test records (filled form) will be kept on file as a quality record
    13.2. Route cards for manufactured units
    13.3. Sterilization records
    13.4. Any additional relevant information
    13.5. XXX
    13.6. XXX

    14. Results & analysis


    Test records shall include:
    14.1. Test equipment identification
    14.2. Sample tractability
    14.3. Test data
    14.4. Statistical analysis
    14.5. Identification of the person performing the test
    14.6. Protocol deviations if needed
    14.7. XXX
    14.8. XXX

    15. Revalidation / requalification


    15.1. …

    Confidential
    Verification & Validation RDR-XXXXX
    Document Name Test Report
    Month, 20YY Page 5 of 5 pages Revision 01

    16. List of Appendixes

    Confidential

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