DUBLIN, Ireland, June 07, 2022 - Deciphex have announced today that they are first in industry to offer clients Good Laboratory Practice (GLP) compliant digital primary review. The release of the 2.2 version of Deciphex’s Patholytix software now facilitates the ease of validation of a digital GLP workflow. This is a major milestone as regulatory validation of digital pathology software is needed before its use in performing GLP-compliant primary review.
This has been achieved by the implementation of a number of technical controls within Patholytix. These new technical controls will allow users to validate the software for regulated intended use in primary review. This directly builds on the existing controls to support regulated peer review. In 2021, Deciphex announced with Charles River Laboratories that they were first in industry to enable digital GLP-compliant peer review of non-clinical safety assessment studies.
For a candidate drug to be acknowledged as safe to be used in clinical trial testing on humans, non-clinical studies must be carried out in line with GLP regulations. For traditional study review, the Test Facility must be determined to fit the criteria of a GLP-compliant facility. However, in recent years, more and more study reviews are being conducted digitally. This means the digital environment in which a study is reviewed must be validated also. Several organisations are now opting for digital study review over non-digital options. This is due to the benefits of being a more efficient and streamlined process, as well as the added potential of applying artificial intelligence to analyse whole slide images, a capability not possible with traditional glass slides.
The primary review process is normally carried out by the organisation that conducts the animal study, whether that is a pharmaceutical or biotechnology company, or a contract research organisation (CRO). When performing drug safety assessment studies, it is not necessary to perform peer reviews in a GLP-regulated environment. However, it is mandatory that the primary review process is carried out in a GLP-compliant manner. Up until now, no digital pathology platform has been qualified to perform GLP compliant primary review of digital studies.
Patholytix now offers an end-to-end GLP-compliant workflow for both primary and peer review of drug safety studies. The software enables organisations to review both GLP and non-GLP studies all in one place. Users will have the ability to configure compliance settings at a site level to validate in accordance with their regional regulatory requirements. This will be relevant to organisations with sites in different countries that operate under different GLP guidelines, allowing Deciphex’s software to be validated within the regulations of all major regulatory bodies. These include the Food and Drug Administration (FDA) and OECD adherent regulatory bodies such as the MHRA, SwissMedic and others.
Deciphex also offers Computer Systems Validation (CSV) services to help customers meet GLP regulatory and data integrity requirements. This is achieved through comprehensive validation guidance by dedicated CSV resources. These resources offer end-to-end project management and documentation support to ensure a thorough and effective validation process. Successful validation requires highly refined documentation to guide compliant functional and acceptance testing. The support services provided by Deciphex aim to save time during the drug development process by accelerating the GLP validation process resulting in a more cost effective approach compared to sourcing in-house expertise.
Commenting on this, General Manager of Research Pathology, Shane Ryan says:
“Ensuring the Patholytix Preclinical SaaS meets the needs of our clients is Deciphex’ top priority. Use of our services for regulated intended use will ultimately have a profound impact on Safety Assessment and the overall Drug Development life cycle.“
Over the next number of months, Deciphex will be supporting many of their partners to validate their Patholytix software to perform GLP primary review. If you wish to discuss how we can help you validate your organisation's digital pathology workflow for GLP primary review email firstname.lastname@example.org.
*Deciphex provides GLP qualified software informed by industry best practice (GAMP5). Any customer wishing to use the software for GLP applications will be required to perform the necessary validation as dictated by their regulatory authority for the intended use case
Deciphex is a global software company focused on developing digital pathology-based software and services for clinical and research pathology. Our ambition is to network and accelerate the world's pathologists. We believe that digital pathology combined with artificial intelligence will help make pathologists work more efficiently, offering a solution to the pending challenges in supply/demand in pathology services. Deciphex plans to be at the forefront of this revolution with cleverly positioned solutions that deliver on the biggest problems facing pathology today.
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