GDP良好的文件规范 presentation.ppt

Affixed Documents Items should be permanently affixed with tape or glue. However stapling is allowed. When items are affixed by tape within a page an embossing signature is required. An Embossing signature is a signature that begins on the page. The embossing signature crosses over the tape and it completed onto the item affixed. Affixed items may be overlaid but should be staggered, if possible, and in the same orientation. If the supporting data is a printout is light or heat sensitive, carefully store the original to protect it from light and extreme temperatures 附件 各项附件需用胶纸或胶水永久性粘牢。装订也可。 当用胶纸将各项附件粘在一页之上时，需使用压印签名。压印签名是指从原纸页上开始，越过胶纸，最后在粘好的附件上完成。 粘附的各附件可重叠，但要有层次（错开），且方向要一致。 如果支持数据为光敏或热敏打印件，要细心存放原始数据，避免光线及高温或低温。 Reviewer Responsibilities Reviewer (verifier). The Reviewer is the person (peer, supervisor, designee) assigned overall responsibility for reviewing all original data recorded. The Verifier (reviewer) signature indicates that the original data was reviewed for: Compliance to Good Documentation Practices Compliance to applicable SOPS, protocols, specifications Accuracy, completeness, legibility, and organization. All calculations are to be recalculated by the verifier The verifier confirms that the printed name accompanies stylized signatures somewhere in the document or Company signature log 审核员职责 审核员：被指派全权负责审核所有原始数据记录的人员（同级、主管、被指定负责人）。审核员签名表明原始数据经审核符合以下内容： 符合良好文件规范（GDP） 符合程序文件、计划、规格 准确性、完整性、可辨性以及条理性 所有计算数据经由审核员重新计算过 审核员确认记录中的个性签名与在文件中或公司签名簿中提供的印刷姓名相符。 Questions? 提问 Good Documentation Practices Thomas Feldsien A Guide to Good Documentation Practice: Medical Device Projects 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 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 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