Society of Toxicologic Pathology Position Paper on Pathology Image Data: Compliance with 21 CFR Parts 58 and 11

Darrell L. Tuomari, Ramon K. Kemp, Rani Sellers, John T. Yarrington, Frank J. Geoly, Xavier L.M. Fouillet, Noel Dybdal, Rick Perry

Research output: Contribution to journalArticlepeer-review

39 Scopus citations


The Society of Toxicologic Pathology (STP) has developed the following recommendations for the use of pathology images in compliance with the Code of Federal Regulations (CFR), Volume 21, Part 58 (Good Laboratory Practices [GLP]) and Part 11 (Electronic Records/Signatures). These recommendations include: (1) based on current technologies and practices, pathology images (printed, electronic, or digital) used for data generation (e.g., to make a diagnosis or for morphometric analysis) are raw data that must be authenticated and archived; (2) authentication of an image may be done either by initialing and dating a print of the image or by specifically annotating the electronic image file in compliance with Part 11 regulations; (3) images used for raw data are subject to GLP procedures and controls in order to ensure data integrity including written Standard Operating Procedures, testing/validation of equipment, training of personnel, etc.; (4) validation and/or performance qualification of imaging systems used to support GLP studies must be documented and any exceptions to full validation/qualification must be described in the GLP Compliance Statement for the study; (5) images that are not used for data generation are illustrative images, are not raw data, and generally do not have to be archived; 6) illustrative images should not be used to re-evaluate or supersede the pathologist’s diagnosis.

Original languageEnglish (US)
Pages (from-to)450-455
Number of pages6
JournalToxicologic pathology
Issue number3
StatePublished - Apr 2007

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Molecular Biology
  • Toxicology
  • Cell Biology


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