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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
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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