GDP良好的文件规范（可修改）.ppt

良好的文件规范 对失误跳过空白地方或空白页，要划掉整个空白区域，标记为“空白”，并给予简要说明，签姓名缩写。 不允许使用同上标记(“ ”) 记录原始数据。记录重复数据信息，如日期、规格、时间等等，可用箭头标明。但是，箭头不可用于记录最终结果。 优选文档 * Red-line Red-lineA field change to an approved document (not original data) that defines a controlled process. This is not an error correction, such as when an observation value is recorded in error.Redlines must be approved by Customer under change notice or deviation before implementation 优选文档 * 红线更改 红线更改 对批准的过程控制文件（非原始数据）进行现场更改。 这不是错误修正，例如改正观察值记录错误。 在实施红线更改之前，必须经过客户做出永久或临时变更批准。 优选文档 * Error Corrections Incorrect entries must be lined out with a single line, initialed and dated. Do not erase, blot out, or otherwise obscure, (i.e., no liquid paper, white out, ‘scratch’, etc.) It should be clear what is: the wrong data the correct data the reason for the correction the date each was recorded the person recording them Any corrections must be accompanied with a detailed explanation. Write in the correct entry, initial and fully explain the correction. 优选文档 * 优选文档 Good Documentation Practices Thomas Feldsien A Guide to Good Documentation Practice: Medical Device Projects 优选文档 * 良好的文件处理规范（GDP） 　良好的文件处理规范指南： 　　　　　医疗器械产品 Thomas Feldsien 优选文档 * Objectives Provide an overview of FDA expectations and standard industry practice of documentation skills for the development and manufacture of medical devices. Identify Data Recorder Responsibilities Identify Data Reviewer Responsibilities 优选文档 * 目的 提供有关FDA对于医疗器械开发和生产文件规范的期望和医疗产品生产行业有关医疗器械开发和生产文件管理的技能 确定数据记录员的职责 确定数据审核员的职责 优选文档 * Documentation is the key to a successful GMP/QSR audit. Documentation should be complete, accurate, legible and organized. “If it is not written down, it didn’t happen.”  -the FDA When entries are made in a clear readable manner, it demonstrates to an auditor that the personnel who have completed the task have quality consciousness that will help ensure a safe and effective product. Why GDP? 优选文档 * 为什么要实行GDP？ 文件是成功通过GMP/QSR审核的关键。文件内容完整、准确、清晰明了、条理分明。 “