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Change Control for Validated Systems (RiskVal)

Once a computer system is validated, it must be placed under change control. The FDA and ISO 13485 require that changes to validated computer systems be approved in advance. The change and the system must be appropriately tested to ensure that the change is effective and that it hasn't inadvertently negatively impacted the system's ability to meet requirements. This document describes a practical change control process and provides an approval form. 17 pages

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  • This document describes the procedure for making changes to validated systems.
  • This procedure applies to all components of a validated computer system. These items are identified either in the Validation Plan for the system or a separate controlled system description, such as a system specification.
  • Validation testing is conducted per the instructions given on the CSCR or the Validation Plan for the system, and in compliance with the company validation policies and procedures. Protocols are developed as appropriate. If the validation testing is short, it may be specified on the change request for as permitted in the validation procedure (e.g., VAL003).
  • Enhancement – An enhancement to the system through the addition of functionality or improvement of equipment. An enhancement has the potential to change how the system functions or manages data. An enhancement also could impact other equipment/systems or production.

It Provides information on:

  • Responsibilities
    • Requester
    • Computer System Change Control Board
    • Information Technology
  • Method
    • Assessments of the change
    • Validation of the change
    • Completion and Notification
    • Filing
    • Emergency Changes
  • Quality Records

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