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

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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