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.
• 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