[洛施德咨询] 数据完整性培训 20150320.pdf

数据完整性暨计算机系统验证整改重点培训 Mar 20, 2015 洛施德企业管理咨询 (上海) 有限公司 Michael Hsu / 许哲毓 Execution Director 执行总监 michael.hsu@ 本教材版权属于洛施德，请勿任意拷贝或上传至互联网，或做未授权商业使用 1 of 62 “your preferred Partner to Compliance” 介绍大纲 √  数据完整性的定义和重要性  FDA对于数据完整性问题的态度  制药/生命科学行业中普遍存在的数据完整性问题  确保数据完整性的整改步骤  计算机系统验证的体系介绍  洛施德咨询公司简介 本教材版权属于洛施德，请勿任意拷贝或上传至互联网，或做未授权商业使用 2 of 62 “your preferred Partner to Compliance” What constitutes Data to the Pharmaceutical / LifeScience Industries? 制药/生命科学行业的数据构成 • Manufacturing Batch records 生产批记录 • Quality Control Testing Records 质量控制检验记录 • Calibration Records 校准记录 • OOS Records OOS记录 • Clinical Trial Data 临床试验数据 • Equipment Master List 总设备清单 Its anything that is recorded directly or indirectly supporting the manufacturing of a Pharmaceutical Product. • Etc… 等等 所谓数据，就是用于支持药品生产的所有直接或间接记录。 本教材版权属于洛施德，请勿任意拷贝或上传至互联网，或做未授权商业使用 3 of 62 “your preferred Partner to Compliance” Why is Data Integrity so Important to the Pharmaceutical / Life Science Industries? 为什么对制药/生命科学行业来说，数据完整性至关重要 ？ Data integrity is a prerequisite for the regulated healthcare industry as decisions and assumptions on product quality and compliance with the applicable regulatory requirements are made based on data. Drug and medical device manufacturers or service providers, healthcare organisations, regulators and other government organisations, and users (patients and healthcare professionals) rely on data. Breaches in data integrity can have negative consequences and may lead to patient injury, or even