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所在平台: Udemy |
课程主页: https://www.udemy.com/course/spreadsheet-validation-based-on-gamp5/
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**课程名称：** 基于GAMP 5的电子表格验证 **课程概述：** 本课程专注于在GxP（良好实验室规范、良好生产规范等）环境下，对Excel电子表格这一特殊的计算机化系统进行验证。电子表格在GxP中常用于数据存储和计算，因此其验证需要特别考虑设计、需求、风险评估和测试用例等方面。 **课程目标：** * 深入了解Microsoft Excel电子表格验证的具体方面。 * 学习如何对Excel电子表格进行分类和归档。 * 掌握基于GAMP 5（良好自动化制造规范）的Categorization 5和Categorization 4电子表格的验证方法。 * 了解电子表格验证相关的特定需求和测试用例。 * 学习良好的电子表格设计实践。 **课程内容范围：** * 引言 * 电子表格的分类与归档 * 基于分类的电子表格验证 * 电子表格的特定需求 * 电子表格开发 - 良好实践 * 电子表格的资格鉴定协议细节 * 电子表格的运营和退役细节 **核心要点：** 根据GAMP 5指南进行电子表格验证，对于确保在受监管环境中的数据完整性和可靠性至关重要。GAMP 5为验证计算机化系统（包括电子表格）提供了一个全面的框架。验证过程包括风险评估，其中关键性和复杂性决定了验证活动的程度。电子表格的验证包括核实公式、数据完整性以及用户访问控制。GAMP 5还强调在整个验证生命周期中维护全面文档的必要性。遵循这些指南可确保基于电子表格的系统满足法规要求，降低关键数据出错和不准确的风险，最终支持受监管行业的数据完整性。
Validation of Excel Spreadsheets: Spreadsheets are specialized computerized systems utilized in GxP to store and calculate data. Validating such systems involves specific considerations related to design, requirements, risk, and test cases.The goal of the course:Explore specific aspects of MS Excel spreadsheet validationFind out how to categorize MS Excel spreadsheetsLearn how to validate spreadsheets based on categories 5 and 4Learn about specific requirements and test cases related to spreadsheet validationFind out good spreadsheet design practicesScope of the course:IntroductionSpreadsheet classification & categorizationSpreadsheet validation based on categoriesSpecific spreadsheet requirementsSpreadsheet development - good practicesQualification protocol specifics for spreadsheetsOperational & retirement specifics for spreadsheetsSpreadsheet validation, as per GAMP 5 guidelines, is crucial to ensure the integrity and reliability of data in regulated environments. GAMP 5, the Good Automated Manufacturing Practice guide, provides a comprehensive framework for validating computerized systems, including spreadsheets. The validation process involves risk assessment, where criticality and complexity determine the extent of validation activities.Validating spreadsheets includes verifying formulae, data integrity, and user access controls. GAMP 5 also stresses the need for maintaining comprehensive documentation throughout the validation lifecycle. Adhering to these guidelines ensures that spreadsheet-based systems meet regulatory requirements, reducing the risk of errors and inaccuracies in critical data, and ultimately supporting data integrity in regulated industries.
