PDA-数据完整性行为守则要素.docxVIP

PDA-数据完整性行为守则要素(中/英对照版)徐禾丰2016-04-22 09:53 来自QQ空间日志Parenteral Drug Association Points to Consider注射剂协会考虑要点Elements of a Code of Conduct for Data Integrity数据完整性行为守则要素Introduction简介Data Integrity has been and currently is a major global concern of Health Authorities and the pharmaceutical industry.Although not a new issue, numerous recent Health Authority enforcement actions such as Warning Letters, Import Alerts, Product Detentions, and suspension or revocation of Marketing Authorizations has focused attention on Data Integrity.Data Integrity can result from lack of awareness of regulatory requirements, employee errors, failure to check accuracy of data, software or system malfunction, or configuration problems with electronic data handling, or malfeasance by employees.To holistically address Data Integrity, the Parenteral Drug Association (PDA) is developing a set of tools in the form of PDA Technical Reports, PDA Training Program, Data Integrity Workshops, and Points to Consider documents that can be used by industry to address this serious issue.This document presents the views of the Parenteral Drug Association (PDA) on the benefits for companies to voluntarily adopt a Code of Conduct for assuring data integrity.数据完整性目前已经成为全球卫生机构与制药行业所关注的重点。尽管不是一个新的问题，近期在很多卫生当局的执法行动例如警告信、进口警报、产品扣留，以及暂时取消或撤销上市许可中都非常关注数据完整性的问题。数据完整性可能由于缺乏法规要求意识、员工错误、无法核实数据准确性，软件或系统故障，或电子数据处理配置问题，或员工渎职行为导致。为了全面解决数据完整性问题，注射剂协会(PDA)正在开发一套面向行业的涵盖PDA技术报告、PDA培训程序、数据完整性研讨会，以及考虑要点文件的工具来解决这一严重问题。本文件代表注射剂协会(PDA)的观点，公司可自愿采用行为守则来确保数据完整性。How to Use this Document如何使用本文件This document was developed by a team with expertise in the fields of quality, regulatory affairs, auditing, and manufacturing and reviewed by attorneys specialized in food, drug and labor law. This document is written for easy adoption, in part or in its entirety, by companies, if they so choose, without the need for extensive rewriting of the document. Therefore, the terms ‘shall’ and ‘must’ have been used to permit the Code to be enforceable by