Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

4 Good Documentation Practices • Good Documentation Practice (GDP) is a systematic procedure of preparing, reviewing, approving, issuing, recording, storing and archiving of

为了确保数据完整性人员在纸质记录和电子记录方面都要遵循GDocP。 这些原则需要文件有一个可追溯的、清晰的、同步记录的、原始的和准确的（有时称之为ALCOA）的特性。

2024年9月12日 · Good documentation practice (GDocP) is a crucial component of regulatory compliance, including data integrity assurances. Referred to in the industry as Good Recordkeeping Practice (GRK), the term good documentation practice generally involves adhering to ALCOA+ principles.

2019年11月3日 · In recent years, the number of observations made regarding the integrity of data, documentation and record management practices during inspections of good manufacturing practice (GMP), good clinical practice (GCP) and good …

2017年4月17日 · 为了确保数据完整性人员在纸质记录和电子记录方面都要遵循gdocp。这些原则需要文件有一个可追溯的、清晰的、同步记录的、原始的和准确的（有时称之为alcoa）的特性。这些重要的特性同等应用于纸质和电子记录。

2023年10月2日 · In this article, we’ll detail how the FDA’s ALCOA+ framework is interlinked with having strong GDocP standards in place, and share a journey of establishing and maintaining good documentation practices. Finally, we’ll widen out, addressing principles of good documentation, as well as find out how it can revolutionize your operations.

2024年3月24日 · 在此附件中的表格提供了纸质和电子记录和系统的常规 ALCOA 要求实施的进一步的指导。 另外，详细的风险管理的实例以及几个例证演示了这些措施是如何典型实施的。 这些例证提供来帮助理解概念和如何达到基... 12-1 WHO 数据完整性指南：良好的数据和记录规范（最终版）中文版 --实例部分附件 1 在纸质和电子系统中实施 ALCOA (+) 的期望和详细风险管理考虑的实例为了保证记录和数据在他们整个使用期间即数据生命周期内的准确、完整、一致和可靠 …

良好文档管理规范，通常缩写为GDP或GDocP，是一套适用于需要高度制度规范管理的行业标准，如制药或医疗器械行业，概述了如何创建、维护和控制与生产和供应链有关的文件。

2024年6月11日 · Whether it pertains to pharmaceuticals, biotechnology, medical devices, or other highly regulated industries, GDocP plays a pivotal role in maintaining compliance with regulatory standards. This blog delves into what GDocP entails, its importance, key components, and the best practices that organizations should adopt.