Julie Boisclair, Bhupinder Bawa, Erio Barale-Thomas, Lise Bertrand, Jonathan Carter, Richard Crossland, Celine Dorn, Thomas Forest, Sabine Grote, Anja Gilis, Deon Hildebrand, Brian Knight, Sébastien Laurent, Heike Antje Marxfeld, Steen Jørgen Østergaard, Thibault Roguet, Thorsten Schlueter, Vanessa Schumacher, Richard Spehar, William Varady, Christian Zeugin
{"title":"IT/QA and Regulatory Aspects of Digital Pathology: Results of the 8th ESTP International Workshop.","authors":"Julie Boisclair, Bhupinder Bawa, Erio Barale-Thomas, Lise Bertrand, Jonathan Carter, Richard Crossland, Celine Dorn, Thomas Forest, Sabine Grote, Anja Gilis, Deon Hildebrand, Brian Knight, Sébastien Laurent, Heike Antje Marxfeld, Steen Jørgen Østergaard, Thibault Roguet, Thorsten Schlueter, Vanessa Schumacher, Richard Spehar, William Varady, Christian Zeugin","doi":"10.1177/01926233221113275","DOIUrl":null,"url":null,"abstract":"<p><p>Digital toxicologic histopathology has been broadly adopted in preclinical compound development for informal consultation and peer review. There is now increased interest in implementing the technology for good laboratory practice-regulated study evaluations. However, the implementation is not straightforward because systems and work processes require qualification and validation, with consideration also given to security. As a result of the high-throughput, high-volume nature of safety evaluations, computer performance, ergonomics, efficiency, and integration with laboratory information management systems are further key considerations. The European Society of Toxicologic Pathology organized an international expert workshop with participation by toxicologic pathologists, quality assurance/regulatory experts, and information technology experts to discuss qualification and validation of digital histopathology systems in a good laboratory practice environment, and to share the resulting conclusions broadly in the toxicologic pathology community.</p>","PeriodicalId":23113,"journal":{"name":"Toxicologic Pathology","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2022-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Toxicologic Pathology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/01926233221113275","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/8/11 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"PATHOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Digital toxicologic histopathology has been broadly adopted in preclinical compound development for informal consultation and peer review. There is now increased interest in implementing the technology for good laboratory practice-regulated study evaluations. However, the implementation is not straightforward because systems and work processes require qualification and validation, with consideration also given to security. As a result of the high-throughput, high-volume nature of safety evaluations, computer performance, ergonomics, efficiency, and integration with laboratory information management systems are further key considerations. The European Society of Toxicologic Pathology organized an international expert workshop with participation by toxicologic pathologists, quality assurance/regulatory experts, and information technology experts to discuss qualification and validation of digital histopathology systems in a good laboratory practice environment, and to share the resulting conclusions broadly in the toxicologic pathology community.
期刊介绍:
Toxicologic Pathology is dedicated to the promotion of human, animal, and environmental health through the dissemination of knowledge, techniques, and guidelines to enhance the understanding and practice of toxicologic pathology. Toxicologic Pathology, the official journal of the Society of Toxicologic Pathology, will publish Original Research Articles, Symposium Articles, Review Articles, Meeting Reports, New Techniques, and Position Papers that are relevant to toxicologic pathology.