At Deciphex our mission is to enable our users to facilitate digital peer review of non-clinical pathology studies. We are delighted to announce the upcoming launch of Patholytix Preclinical 2.0 which provides our clients with a pathway to a regulated GLP Peer Review in conjunction with their CRO partners.
We have introduced several technical controls in the product to support computer systems validation in the context of FDA and OECD guidelines and regulations. This includes - the ability to nominate a GLP vs Non-GLP study with clear differentiation and controls within software, the ability to assign a user to a GLP study, logging of relevant system and user events, capturing reason for change with respect to updates of a locked GLP study, and enhancement of existing authentication mechanisms. Deciphex have also augmented internal process controls to facilitate vendor GLP compliance so the outputs of our development processes can be used as inputs to the client validation process.
We are actively collaborating with a number of regulatory experts from CRO and pharma partners to validate the system for GLP Peer Review prior to the end of 2020 enabling the first digital GLP Peer Review shortly thereafter. We will be introducing a range of additional services in 2021 to facilitate client GLP validation, including access to test environments and relevant documentation to support the validation process.
Invent, DCU, Dublin 9, Ireland