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Validation of Computer Systems Used in Production and Quality Systems (RiskVal)

This procedure defines the process for the validation of off-the-shelf and configured computer systems. Deliverables are clear defined. It is a practical guide for the validation of high-, moderate- and low-risk systems to meet FDA's requirements and ISO 13485. In addition, the procedure includes practices to manage the risks associated with computer system failures. This procedure is based on the RiskVal Life Cycle described in The Computer System Risk Management and Validation Life Cycle (Paton Press, 2006). 26 pages

Provider: BPA
Shipping: Available for download - Link will be provided in My ComplianceOnline section

Price: $49.00
Product Details

  • This procedure defines the process for the validation of off-the-shelf and configured computer systems. Deliverables are clear defined. It is a practical guide for the validation of high-, moderate- and low-risk systems to meet FDA's requirements and ISO 13485.
  • ISO 13485 and Part 11 require that validations be conducted according to defined procedures.
  • This procedure will save you time in your validations because it defines how to reduce what is done and the level of documentation for the validation for moderate- and low-risk systems.
  • This procedure is written WITHOUT using the phase concept of the Risk Val Life Cycle , but it includes the deliverables from the Life Cycle.

It Provides information on:

  • Responsibilities
  • Method
  • Quality records

 

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