Life Cycle for the Selection, Implementation, Validation and Use of Computer Systems (RiskVal Life Cycle)

This procedure defines the requirements for the validation of off-the-shelf and configured computer systems. It takes a life cycle approach that spans from the initial need for a system through requirements development, systems selection, system implementation and risk mitigation, validation testing, system use, and retirement. This life cycle, called RiskVal is described in detail in The Computer System Risk Management and Validation Life Cycle (Paton Press, 2006). It is a practical guide for the validation of high-, moderate- and low-risk systems to meet FDA's requirements and ISO 13485. 32 pages.

Provider: BPA
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  • The purpose of this procedure is to define the requirements and process for the selection, validation, use, and retirement of off-the-shelf and/or configurable computer systems used for GXP activities and/or in conjunction with quality records.
  • Assuring that the system is used in a compliant manner, including: preparing user and administrative procedures, training users, participating in the assessment, approval and implementation of changes, and taking appropriate corrective actions to resolve any compliance issues.
  • A system for which the highest potential risk from a failure or hazard is estimated to be intolerable or high in the ALARP (As Low As Reasonably Practicable) range. (See RISK006 for an exact description of how the ALARP zone is split between moderate and high risk.)
  • A life cycle approach is taken to the selection, development, validation, and use of computer systems in order to ensure that they will perform reliably. Testing cannot fully verify that software is complete and correct. In order to be assured that a computer system will consistently meet requirements through specified operating ranges, the system must be selected, implemented, and controlled in an appropriate manner.
  • Phase the planned mitigation actions are implemented and their impact assessed, and a system specification is created for the system.

It Provides information on:

  • Responsibilities
    • Project Team
    • System Owners are responsible for
    • Quality Assurance (QA) is responsible for
  • Method
    • Life cycle approach
    • Conceptualize
    • Select Vendors and Systems
  • Quality Records

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