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PIC/S gives ECA the Opportunity to comment on PI 041-1 (Draft 3) - Data Integrity
Pharmaceutical inspectors from more than 50 countries have joined the Pharmaceutical Inspection Co-operation Scheme by now. One of the main objectives of the PIC/S is developing harmonised GMP/GDP guidelines. The PIC/S provides guidelines - PIxxx- for its inspectors which are aimed to support them in the course of inspections. These documents are publicly available and present possible questions arising during authority inspections. 现时已有超过50个国家的药企监察人员加入药物检验合作计划。PIC/S的主要目标之一是制定协调的GMP/GDP指南。PIC/S为检查员提供了指南- PIxxx，目的是在监察过程中支持他们。这些文件是公开的，并提出当局视察期间可能出现的问题。 The PIC/S is currently working on the elaboration of guidance PI 041-1 "Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments". The second draft of the document was originally published on 10 August 2016 and released for discussion. The extensive internal comments have been consolidated by the PIC/S and resulted in a revised third draft. This third draft was published on 30 November 2018. PIC/S目前正致力于制定PI041 -1指南“GMP/GDP环境中数据管理和数据完整性的良好实践”。该草案第二稿最初于2016年8月10日发表并发布讨论。广泛的内部意见已加以合并，从而产生了订正的第三份草案。草案第三稿在2018年11月30号发布。 In addition to other organisations, the ECA has been invited to comment this new draft. For that purpose you will find a PDF comparing Draft 2 and 3 and the template for your comments in theECA website members' area. For more information on the new PIC/S guidance draft please see the PIC/S website. 除其他组织外，ECA也应邀对这项新草案发表评论。为此目的，你可以在ECA网站会员区找到一份PDF文件，比较草案2和3，以及可以下载评论模板。更多关于PIC/S草案信息详见 PIC/S website. For your information here are the contents and the main changes of the third draft of PIC/S PI 041-1: 以下是第三稿草案的主要变化： - The document's basic structure (made of 14 chapters) has been maintained.
- 文件的基础结构（由14章组成）保留。
1. Document history 文件历史
2. Introduction 引言
3. Purpose 目的
4. Scope 范围
5. Data governance system 数据管理体系
6. Organisational influences on successful data integrity management 公司对成功的数据管理的影响
7. General data integrity principles and enablers 一般数据完整性原则和推进因素
8. Specific data integrity considerations for paper-based systems 纸质系统数据完整性具体考量
9. Specific data integrity considerations for computerised systems 计算机系统的数据完整性具体考量
10. Data integrity considerations for outsourced activities 外包活动的数据完整性考量
11. Regulatory actions in response to data integrity findings 数据完整性缺陷引起的监管行动
12. Remediation of data integrity issues 数据完整性缺陷补救
13. Definitions 术语
14. Revision history 变更历史 - Subchapter 8.9 "Maintaining records" has been removed.
- 第8.9分章“记录维护”已删除。
- A new subchapter 9.8 "Management of Hybrid Systems" has been added.
- 增加了一个新的分章9.8“混合系统的管理”。
- Significant and comprehensive extensions have been made to the subchapters 9.3 "System security for computerised systems" and 9.4 "Audit trails for computerised systems".
- 对第9.3分章“计算机系统的系统安全”和第9.4分章“计算机系统的审计跟踪”作了重大和全面的扩展。
- A document comparison between the second and the third draft is available in the Members' Area of the ECA Data Integrity & IT Compliance Group.
- ECA数据完整性和信息技术遵守小组成员区域内提供了第二份和第三份草稿之间的文件比较。
https://www.gmp-compliance.org/gmp-news/pic-s-gives-eca-the-opportunity-to-comment-on-pi-041-1-draft-3-data-integrity
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发表于 2018-12-4 09:14:40
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