1.1 本指南适用于从提供原材料的供应商向接收原材料的客户传输的原材料电子数据（eData）的所有元素。 1.2 本指南是为制药和生物制药制造商及其供应商开发的，但可能适用于常规传输数据的其他行业。 1.3 该指南也适用于供应链中公司之间的原材料eData转移。 1.4 本指南适用于新的和现有的原材料。 1.5 本指南适用于原材料的生命周期（即原材料整个加工阶段生成的数据），不依赖于供应商或客户。 1.6 本指南描述了eData标准的两个主要方面:数据格式和数据内容，包括分类法和命名法。 1.7 该指南目前仅涵盖英文版的数据内容和数据格式。数据格式不得翻译。对本指南范围之外的数据内容使用其他语言。 1.8 该格式基于可扩展标记语言（XML）1.0。 1.9 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 本指南中所述方法的应用旨在实现生物制药行业范围内的标准格式，该格式可用于供应商和客户之间的电子数据传输，以监测和研究可变性。 5.2 本指南支持并促进快速数据传输，从而避免数据重新捕获、人机交互和转录错误；从而实现更精简的业务流程。 5.3 如果eData结构不符合本指南定义的XSD，则不能保证其可互操作。反馈或变更请求应发送至ASTM总部，提请委员会E55员工经理注意。 5.4 可以采用数字签名并将其用作eData传输的一部分。XML和XSD以两种格式提供:有数字签名配置和没有数字签名配置。用户可以使用任意一种格式来实现，以确保符合ASTM eData XSD结构。

1.1 This guide is applicable to all elements of raw material electronic data (eData) transfer from a Supplier which provides a raw material to a Customer which receives the raw material. 1.2 This guide is developed for pharmaceutical and biopharmaceutical manufacturers and their suppliers, but may be suitable for other industries that routinely transfer data. 1.3 The guide may also be applicable to raw material eData transfer between companies in the supply chain. 1.4 The guide is applicable to new and existing raw materials. 1.5 This guide is applicable to the life-cycle of a raw material (that is, data generated throughout the processing stages of the raw material) and is not dependent on the Supplier or Customer. 1.6 This guide describes two major areas of eData standard: the data format and the data content including the taxonomy and nomenclature. 1.7 The guide currently only covers data content and data format in the English language. The data format shall not be translated. Use of other languages for the data content outside the scope of this guide. 1.8 The format is based on Extensible Markup Language (XML) 1.0. 1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 5.1 Application of the approach described within this guide is intended to achieve a biopharma industry-wide standard format that will be available for electronic data transfer between Supplier and Customer for monitoring and studying variability. 5.2 This guide supports and facilitates fast data transfer, thereby avoiding data recapture, human interaction, and transcription errors; and thus enables a more streamlined business process. 5.3 If the eData structure does not conform to the XSD defined by this guide then it is not guaranteed to be inter-operable. Feedback or change requests should be directed to ASTM Headquarters, to the attention of the Committee E55 Staff Manager. 5.4 Digital Signature can be adopted and used as part of the eData transfer. XML and XSD are provided in two formats: with and without digital signature configuration. User can follow either format for implmenation to ensure conforming with the ASTM eData XSD structure.