GLP AND DIGITAL PATHOLOGY

Adoption of digital slides is rapidly expanding in the biopharma industry, and a key part of this will be the use of digital slides in a GLP environment, both for preclinical safety studies and clinical trials. We offer a GLP Compliance Software Module within our Spectrum information management system. For the latest information on GLP and complete IQ/OQ/PQ validation services, please contact our professional services compliance team.

Below, please find a sampling of presentations and discussions made by Aperio on the topic of GLP.

• Premarket specification to industry of what was required from digital pathology vendors in December 2007 (PDF)
• Overview of GLP and IQ/OQ/PQ with digital pathology (PDF)
• Invited presentation at PhRMA (PDF)
• Invited presentation at New York Academy of Sciences (PDF)
• ACVP 2008 Annual Meeting (PDF)
• Poster presentation at STP (PDF)
• Poster presentation at ESTP (PDF)

For an overview of the 21 CFR Part 11 and equivalent geographic regulations, please see the following:

• US 21 CFR Part 11 (PDF)
• European Union Annex 11 (English) (PDF)
• European Union Annex 11 (German) (PDF)
• Japanese ERES guidelines (Japanese) (PDF)

Equivalency of Digital Read with a Glass Slide and Microscopes

Aperio has invested substantial resources in validating the usage of a digital slide remotely as it compares with a microscope and glass slide. For comparisons between these two methods, please see the following information:

• Reading Digital IHC Slides on a Computer Monitor (PDF)
• Consistent IHC HER2 Image Analysis on ScanScope Systems (PDF)
• Performance Comparison of a Digital Pathology Solution for IHC to Conventional Manual Microscopy (PDF)
• Validation Studies of Digital IHC (PDF)

Contact us for more information about our solutions for digital pathology.