This procedure defines the methods used to validate any special processes for production and service provision at a company.
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This procedure defines the system used for Product Identification and Traceability.
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This procedure defines the use of Production Travelers to control the production processes at a company.
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This procedure defines the maintenance performed on equipment to maintain production processes at a company.
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This procedure defines the system used for handling, storage, packaging, preservation, and delivery of product.
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This procedure defines the system used for Inspection and Testing at a company.
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The purpose of this procedure is to define the system used for internal quality audits.
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Life Cycle for the Selection, Implementation, Validation and Use of Computer Systems (RiskVal Life Cycle)
This procedure defines the requirements for the validation of off-the-shelf and configured computer systems. It takes a life cycle approach that spans from the initial need for a system through requirements development, systems selection, system implementation and risk mitigation, validation testing, system use, and retirement. This life cycle, called RiskVal is described in detail in The Computer System Risk Management and Validation Life Cycle (Paton Press, 2006). It is a practical guide for the validation of high-, moderate- and low-risk systems to meet FDA's requirements and ISO 13485. 32 pages.
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Requirements for Computer System Requirements, Validation Plans, Protocols and Reports (RiskVal)
This procedure provides detailed outlines of what needs to be included in the most important computer system validation deliverables, including requirements, validation plans, IQ, OQ and PQ protocols, protocol reports, and the validation final report. This procedure is of great value to those who are not familiar with these types of documents and those who want to verify that what they are including in their documents is what auditors look for. 20 pages
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