Computers are widely used during development and manufacturing of drugs and medical devices. Correct functioning and performance of software and computer systems play a major role in obtaining consistency, reliability and accuracy of data.
Product Id: 501068 Provider: LabCompliance Shipping: Available for download - Link will be provided in My ComplianceOnline section
Describes procedures for the validation of commercial computer systems as required by regulated healthcare industry.
Product Id: 500006 Author: Dr. Ludwig Huber Shipping: Available for download - Link will be provided in My ComplianceOnline section Source: LabCompliance List Price: $49.00
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The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP).
Product Id: 501069 Provider: LabCompliance Shipping: Available for download - Link will be provided in My ComplianceOnline section
Structured approach and steps for risk-based validation of software and computer systems.Includes a tables with detailed instructions.
Product Id: 501070 Provider: LabCompliance Shipping: Available for download - Link will be provided in My ComplianceOnline section List Price: $49.00
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Describes Principles and procedures on how Internet,Intranet and e-mail can reliably be used in FDA and other regulated environments.Describes documents as required for inspections.
Product Id: 501073 Provider: LabCompliance Shipping: Available for download - Link will be provided in My ComplianceOnline section List Price: $49.00
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The FDA requires that an investigation be conducted whenever an Out-of-Specification (OOS) result is observed. This SOP defines the requirements for dealing with failed test results.
Product Id: 501076 Provider: LabCompliance Shipping: Available for download - Link will be provided in My ComplianceOnline section List Price: $49.00
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Software and computer systems used in analytical laboratories should be validated for compliance and business reasons. Validation helps to generate accurate, reliable and consistent analytical results.
Product Id: 501077 Provider: LabCompliance Shipping: Available for download - Link will be provided in My ComplianceOnline section List Price: $49.00
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This procedure defines the methods used to validate any special processes for production and service provision at a company.
Product Id: 500164 Provider: Quality Rite Shipping: Available for download - Link will be provided in My ComplianceOnline section List Price: $19.00
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This procedure defines the system used for Product Identification and Traceability.
Product Id: 500165 Provider: Quality Rite Shipping: Available for download - Link will be provided in My ComplianceOnline section List Price: $21.00
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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.
Product ID: 501055
Provider: BPA
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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
Product ID: 501056
Provider: BPA
Shipping: Available for download - Link will be provided in My ComplianceOnline section
