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    CSV Vahid

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    ishwarptl123
    The document discusses computer system validation (CSV) and the associated regulatory requirements. CSV is the process of evaluating software to ensure it meets specifications, performs consistently, and ensures data integrity. It aims to confirm software accuracy, reliability, and ability to identify invalid records. The document outlines CSV requirements from various regulations, including FDA 21 CFR Part 11, EU Annex 11, ICH Q7A, and others requiring validation of computerized systems used for regulated processes and clinical trials.

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    CSV Vahid

    Uploaded by

    ishwarptl123
    39 views14 pages
    The document discusses computer system validation (CSV) and the associated regulatory requirements. CSV is the process of evaluating software to ensure it meets specifications, performs consistently, and ensures data integrity. It aims to confirm software accuracy, reliability, and ability to identify invalid records. The document outlines CSV requirements from various regulations, including FDA 21 CFR Part 11, EU Annex 11, ICH Q7A, and others requiring validation of computerized systems used for regulated processes and clinical trials.

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    The document discusses computer system validation (CSV) and the associated regulatory requirements. CSV is the process of evaluating software to ensure it meets specifications, performs consistently, and ensures data integrity. It aims to confirm software accuracy, reliability, and ability to identify invalid records. The document outlines CSV requirements from various regulations, including FDA 21 CFR Part 11, EU Annex 11, ICH Q7A, and others requiring validation of computerized systems used for regulated processes and clinical trials.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    39 views14 pages

    CSV Vahid

    Uploaded by

    ishwarptl123
    The document discusses computer system validation (CSV) and the associated regulatory requirements. CSV is the process of evaluating software to ensure it meets specifications, performs consistently, and ensures data integrity. It aims to confirm software accuracy, reliability, and ability to identify invalid records. The document outlines CSV requirements from various regulations, including FDA 21 CFR Part 11, EU Annex 11, ICH Q7A, and others requiring validation of computerized systems used for regulated processes and clinical trials.

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    © All Rights Reserved
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    COMPUTER SYSTEM

    VALIDATION
    ARIZONA AUTOMATION & TECHNOLOGIES
    Content
    • CSV Purpose
    • CSV Regulatory Requirements

    ARIZONA AUTOMATION & TECHNOLOGIES


    CSV Purpose
    • Computer system Validation is the process of evaluating the final
    product to check whether the specification meets the user
    expectations and requirements
    • Validation of computer systems to ensure accuracy, reliability,
    consistent intended performance, and the ability to discern invalid or
    altered records is a critical requirement of electronic record
    compliance, as described in the FDA 21 CFR 11.10(a) and EMA Annex
    11, Section 4
    • Known as Computer Validation or CSV

    ARIZONA AUTOMATION & TECHNOLOGIES


    CSV Regulatory
    Requirements

    ARIZONA AUTOMATION & TECHNOLOGIES


    FDA 21 CFR 11 Electronic Record ; Electronic Signatures
    Subpart B—Electronic Records, Sec. 11.10
    Controls for closed systems.
    Such procedures and controls shall include the following :
    (a) Validation of systems to ensure accuracy, reliability, consistent
    intended performance, and the ability to discern invalid or altered
    records.

    ARIZONA AUTOMATION & TECHNOLOGIES


    FDA 21 CFR 820 Quality system Regulation
    Subpart Design Controls, Sec. 820.30(g)
    • Design validation shall include software validation and risk analysis,
    where appropriate
    Subpart G Production and Process Controls , Sec 820 .70 (i)
    • When Computers or automated data processing systems are used as
    part of production or the quality system, the manufacturer shall validate
    computer software for its intended use according to an established
    protocol. All software changes shall be validated before Approval and
    issuance. These validation activities and results shall be Documented.
    ARIZONA AUTOMATION & TECHNOLOGIES
    FDA 21 CFR 211 Current Good Manufacturing Practice for Finished
    Pharmaceuticals
    Subpart D—Equipment , Sec. 211.68(b)
    • Input to and Output from the Computer or related system of
    formulas or other records or data shall be checked for accuracy.

    ARIZONA AUTOMATION & TECHNOLOGIES


    EC Council Directive 93/42/EEC
    ANNEX 1 Essential Requirements
    12.1a For devices which incorporate software or which are medical
    software in themselves, the software must be validated according to
    the state of art taking into account the principles of development
    lifecycle, risk management, validation and verification.

    ARIZONA AUTOMATION & TECHNOLOGIES


    EudraLex Volume 4
    Good Manufacturing Practice, Medicinal Products for Human and
    Veterinary use

    Annex 11 Computerized Systems


    • The application should be validated; IT infrastructure should be
    qualified.

    ARIZONA AUTOMATION & TECHNOLOGIES


    ICH Q7A, Good Manufacturing Practices for Active Pharmaceutical
    Ingredients
    • GMP related computerized system should be validated. The depth
    and scope of validation depends on the diversity, Complexity and
    criticality of the computerized application.

    ARIZONA AUTOMATION & TECHNOLOGIES


    ICH E6 Good Clinical Practice
    When using electronic trial data handling and / or remote electronic
    trial data systems, The sponsor should:

    • Ensure and Document that the electronic data processing system (s)
    conforms to the sponsor’s established requirements for
    completeness, accuracy, reliability, and consistent intended
    performance (i.e. validation)

    ARIZONA AUTOMATION & TECHNOLOGIES


    PIC/S PE 005-3 GMP Guide for Blood Establishment
    • 9.8 The hardware and software of the computers should be checked
    regularly to ensure reliability. The Software (Program) should be
    validated before use.
    PIC/S PE 011-1 Guide to Good Distribution Practice for Medicinal
    Products
    • Before a computerized system is brought into use, it should be
    demonstrated, through appropriate validation or verification studies,
    that the system is capable of achieving the desired results accurately,
    Consistently and reproducibly.
    ARIZONA AUTOMATION & TECHNOLOGIES
    PIC/S PI 011 Good Practices for Computerized Systems used in
    regulated “GXP” Environments
    • 14.1 Regulated users need to be able to provide evidence for their
    computerized systems to demonstrate their range, Complexity,
    Functionality, Control and validation Status.
    • 16.1 Retrospective validation is not equivalent to prospective
    validation and is not an option for new systems.

    ARIZONA AUTOMATION & TECHNOLOGIES


    WHO specification for Pharmaceutical Preparations
    • 6.3 Critical Computerized systems should be validated before use.

    WHO Good Manufacturing Practices for Pharmaceutical Products: Main


    Principles
    • 4.11 particular attention should be paid to the validation of analytical
    test methods, automated systems and Cleaning procedures.

    ARIZONA AUTOMATION & TECHNOLOGIES

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