Long Richard E, Smith Adam, Machotka Sam V, Chlipala Elizabeth, Cann Jennifer, Knight Brian, Kawano Yoshihiro, Ellin Jesus, Lowe Amanda
Charles River Laboratories, Lees Summit, MO 64082, USA.
Toxicol Pathol. 2013 Jan;41(1):115-24. doi: 10.1177/0192623312451162. Epub 2012 Jun 21.
Digital Pathology Systems (DPS) are dynamic, image-based computer systems that enable the acquisition, management, and interpretation of pathology information generated from digitized glass slides. This article provides a roadmap for (1) qualification of a whole slide scanner (WSS) during a validation project, (2) validation of software required to generate the whole slide image (WSI), and (3) an introduction to visual digital image evaluation and image analysis. It describes a validation approach that can be utilized when validating a DPS. It is not the intent of this article to provide guidance on when validation of DPS is required. Rather, the article focuses on technical aspects of validation of the WSS system (WSS, IT infrastructure, and associated software) portion of a DPS and covers the processes of setting up the WSS for scanning a glass slide through saving a WSI on a server. Validation of a computerized system, such as a DPS, for use in a regulated nonclinical environment is governed by Code of Federal Regulations (CFR) Title 21 part 11: Electronic Records; Electronic Signature and predicate rules associated with Good Laboratory Practices documents including 21 CFR part 58. Similar regulation and predicate rules apply in the European Union and Japan.
数字病理系统（DPS）是基于图像的动态计算机系统，可实现对数字化载玻片产生的病理信息进行采集、管理和解读。本文提供了一个路线图，用于（1）在验证项目期间对全切片扫描仪（WSS）进行鉴定，（2）对生成全切片图像（WSI）所需的软件进行验证，以及（3）介绍视觉数字图像评估和图像分析。本文描述了一种在验证DPS时可采用的验证方法。本文的目的不是提供关于何时需要对DPS进行验证的指导。相反，本文重点关注DPS的WSS系统（WSS、IT基础设施和相关软件）部分验证的技术方面，并涵盖从设置WSS扫描载玻片到在服务器上保存WSI的过程。用于受监管非临床环境的计算机化系统（如DPS）的验证受联邦法规（CFR）第21篇第11部分：电子记录；电子签名以及与良好实验室规范文件相关的谓语规则（包括21 CFR第58部分）的管辖。类似的法规和谓语规则适用于欧盟和日本。
