Showing 33–48 of 83 results

  • DQ Reference Sample Storage


    Serial numberVersion
    LDP191021.0
    Created dateLast Updated
    2020-03-06-
    Total PagesTotal Tests
    34 Pages140 Tests

     250

    Design Qualification (DQ) according to URS Reference Sample Storage LDP19022. The scope of this 34 pages long document template is to help you ensure that your Ambient Tempered General Store is designed, delivered, installed, commissioned and qualified according to requirements in URS Reference Sample Storage LDP19022.

    It is made up of 140 individual test numbers divided into sections e.g. capacity, design and installation, material, automation, security, operation (storage and handling), documentation, hygienic design, safety, commissioning and qualification requirements.

    The document template is designed in table form with space for approval and comment for each test as well as final approval of the complete DQ. It is also prepared with a field for signature list, NCR (Non-conformity report) and appendices and references.

  • DQ Safety Cabinet


    Serial numberVersion
    LDP191151.0
    Created dateLast Updated
    2020-03-19-
    Total PagesTotal Tests
    27 Pages196 Tests

     220

    Design Qualification (DQ) according to URS Safety Cabinet LDP19037. The scope of this 27 pages long document template is to help you ensure that your Safety Cabinet is designed, delivered, installed, commissioned and qualified according to requirements in URS Safety Cabinet LDP19037.

    It is made up of 196 individual test numbers divided into sections e.g. capacity, design and installation, material, automation, documentation, hygienic design, safety, commissioning and qualification requirements.

    The document template is designed in table form with space for approval and comment for each test as well as final approval of the complete DQ. It is also prepared with a field for signature list, NCR (Non-conformity report) and appendices and references.

  • DQ Single Door Autoclave


    Serial numberVersion
    LDP191041.0
    Created dateLast Updated
    2020-03-08-
    Total PagesTotal Tests
    40 Pages301 Tests

     350

    Design Qualification (DQ) according to URS Single Door Autoclave LDP19024. The scope of this 40 pages long document template is to help you ensure that your Single Door Autoclave is designed, delivered, installed, commissioned and qualified according to requirements in URS Single Door Autoclave LDP19024.

    It is made up of 301 individual test numbers divided into sections e.g. capacity, design and installation, material, automation, documentation, hygienic design, safety, commissioning and qualification requirements.

    The document template is designed in table form with space for approval and comment for each test as well as final approval of the complete DQ. It is also prepared with a field for signature list, NCR (Non-conformity report) and appendices and references.

  • DQ Single Door Dishwasher


    Serial numberVersion
    LDP190931.0
    Created dateLast Updated
    2020-02-26-
    Total PagesTotal Tests
    37 Pages267 Tests

     350

    Design Qualification (DQ) according to URS Single Door Dishwasher LDP19005. The scope of this 37 pages long document template is to help you ensure that your Single Door Dishwasher is designed, delivered, installed, commissioned and qualified according to requirements in URS Single Door Dishwasher LDP19005.

    It is made up of 267 individual test numbers divided into sections e.g. capacity, design and installation, material, automation, documentation, hygienic design, safety, commissioning and qualification requirements.

    The document template is designed in table form with space for approval and comment for each test as well as final approval of the complete DQ. It is also prepared with a field for signature list, NCR (Non-conformity report) and appendices and references.

  • GMP Training Procedure


    Serial numberVersion
    LDP195051.0
    Created dateLast Updated
    2021-02-05-
    Total PagesTotal Tests
    8 Pages16 Tests

     150

    To provide guidelines to train employee(s) on procedures related to their job performance and to ensure that key personnel involved in the distribution of medicinal products have the appropriate ability and training to guarantee that medicinal products are properly manufactured, stored and handled.

  • Handling of Deviations and Investigation Procedure


    Serial numberVersion
    LDP195001.0
    Created dateLast Updated
    2021-02-02-
    Total PagesTotal Tests
    14 Pages22 Tests

     100

    This procedure covers all unplanned and planned deviations which violate essential GMP rules and affect the quality of products, regulatory and/or operation process.

  • Handling of Recall Procedure


    Serial numberVersion
    LDP195041.0
    Created dateLast Updated
    2021-02-04-
    Total PagesTotal Tests
    16 Pages28 Tests

     150

    This procedure covers all distributed products in all countries. The procedure defines the initiation of the process, collection of the product, verification of recalled products, notification to regulatory authorities and follow up on effectiveness of the recall.

  • Hygienic Design Cleanroom


    Serial numberVersion
    LDP190071.0
    Created dateLast Updated
    2019-12-25-
    Total PagesTotal Tests
    Pages24 Tests

     150

    The scope of this document template is to help you ensure that the cleanroom is designed and installed according to hygienic design. It is made up of 24 individual test numbers. The document template is designed in table form with space for approval and comment for each test. It is also prepared with a field for document number and/or appendix number.

  • Hygienic Design Equipment


    Serial numberVersion
    LDP190061.0
    Created dateLast Updated
    2019-12-25-
    Total PagesTotal Tests
    Pages12 Tests

     150

    The scope of this document template is to help you ensure that your equipment is designed and installed according to hygienic design. It is made up of 12 individual test numbers. The document template is designed in table form with space for approval and comment for each test. It is also prepared with a field for document number and/or appendix number.

  • Invoice Template


    Serial numberVersion
    LDP191211.0
    Created dateLast Updated
    2019-12-29-
    Total PagesTotal Tests
    1 Pages- Tests

     60

    This .pdf invoice template with professional design and smart calculation functions. Features: change logotype currency. If you would like further customization. Send us a message to LexDocPharma.

  • Plant URS Template


    Serial numberVersion
    LDP190511.0
    Created dateLast Updated
    2019-12-25-
    Total PagesTotal Tests
    14 Pages64 Tests

     200

    The scope of this 14 page document template is to give you a toolbox of chapters (headings) for you to fill in the balance information regarding your overall Plant URS. It’s made up of 64 chapters (headings) with general information already filled in.

  • Project Plan Template


    Serial numberVersion
    LDP190501.0
    Created dateLast Updated
    2019-12-25-
    Total PagesTotal Tests
    11 Pages39 Tests

     200

    The scope of this 11 page document template is to give you a toolbox of chapters (headings) for you to fill in the balance information regarding your Project Plan. It’s made up of 39 chapters (headings) with some general information already filled in e.g. project organisation, project activities, project risks, factors for project success etc.

  • Qualification Traceability Matrix


    Serial numberVersion
    LDP190131.0
    Created dateLast Updated
    2019-12-25-
    Total PagesTotal Tests
    Pages Tests

     120

    The scope of this document template is to give you a tool to keep track of where in the qualification chain your individual requirements will be tested. It will give you a clear overview of the requirement/qualification activities as well as help you to sort based on a number of categories. It’s up to you.

  • Risk Assessment and Risk Management System


    Serial numberVersion
    LDP195061.0
    Created dateLast Updated
    2021-02-06-
    Total PagesTotal Tests
    15 Pages46 Tests

     150

    The purpose of the guidance system is to provide tools on how to conduct risk assessment and management.

  • Risk Management Traceability Matrix


    Serial numberVersion
    LDP190111.0
    Created dateLast Updated
    2019-12-25-
    Total PagesTotal Tests
    Pages Tests

     120

    The scope of this document template is to give you a tool to keep track of the status of your risks derived from your risk analysis sessions and documentation. It will give you an overview of the original risk and recommended actions as well as help you to sort risks based on a number of categories. It’s up to you. A

  • Roomcard – Design Input


    Serial numberVersion
    LDP190121.0
    Created dateLast Updated
    2019-12-25-
    Total PagesTotal Tests
    5 Pages93 Tests

     150

    The scope of this 5 pages long document template is to give you a set of room functions and/or functionalities to be answered to fulfill your requirements. It is made up of 93 individual room functions/functionalities. Add, remove and change the document to suite your standard.

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