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Tool to Ensure Compliance


Validation Master Plan Item Information Form (RiskVal)

The Validation Master Plan Item Information Form plays a critical role in the development of a master plan. The form is used to collect information about each of the computer systems that are in use that may need to be validated. Based on the form, the team creating the validation master plan determines if the system needs to be validated and its priority. Here the term “Validation Master Plan” refers to a plan for the validation of all computerized systems at a facility. 7 pages
ProductId:501097
Provider:BPA
Price: $99.0
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Validation Master Plan Template

Companies who have a number of computer systems and are just starting to validate them need to determine what really needs to be validated and the priorities for the validation. Everything cannot be done at the same time; a plan for validation and achieving Part 11 compliance is needed. This template describes the information that needs to be presented in a validation master plan and provides examples. 9 pages
ProductId:501099
Provider:BPA
Price: $99.0
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Validation of Spreadsheet Applications

This document describes how to validate spreadsheet applications such as Excel™. Includes seven attachments with templates for easy implementation.
ProductId:500007
Price: $49.0
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Method Validation

Standard Operating Procedure for Method Validation
ProductId:500237
Provider:Doxpub
Price: $80.0
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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
ProductId:501056
Provider:BPA
Price: $99.0
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Validation Final Report Template (RiskVal)

This template provides extensive instructions and examples for creating a validation report for a specific computer system or piece of equipment.
ProductId:501066
Provider:BPA
Price: $99.0
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Computer System Validation Basic Documentation Package

This package will provide you with the documentation needed to meet the ISO 13495 and Part 11 requirements for a validation procedure.
ProductId:501067
Provider:BPA
Price: $1125.0
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Computer System Validation Master Plan

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.
ProductId:501068
Provider:LabCompliance
Price: $90.0
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Risk-Based Validation of Computer Systems

Structured approach and steps for risk-based validation of software and computer systems.Includes a tables with detailed instructions.
ProductId:501070
Provider:LabCompliance
Price: $49.0
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Validation of Laboratory Computer Systems

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.
ProductId:501077
Provider:LabCompliance
Price: $49.0
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VALIDATION POLICY

Members of regulated companies are often confused about what needs to be validated when. This document sets the validation policy for your company. It identifies when equipment, processes, and computer systems need to be validated at the research, development, clinical, and commercial phases of the product lifecycle. 9 pages.
ProductId:501090
Provider:BPA
Price: $99.0
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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. In addition, the procedure includes practices to manage the risks associated with computer system failures. This procedure is based on the RiskVal Life Cycle described in The Computer System Risk Management and Validation Life Cycle (Paton Press, 2006). 26 pages
ProductId:501096
Provider:BPA
Price: $49.0
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ComplianceOnline
editor@complianceonline.com

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