Each workflow is personalized for a study purpose, with visual indication of a project's progress at a glance. Users are guided through each step including quality controls to validate the data and its integrity.
Make sure your data has been checked and correctly validated through our Electronic Signature (ES) integrated within the platform. Our ES enables to electronically sign the records generated and is in accordance with the 21 CFR Part 11 requirements.
In a GCP context, projects require a total traceability. The vast amount of data generated by digital histopathology analysis makes it extremely challenging from a regulatory standpoint. Our audit trail will automatically keep track of every action performed on the platform to facilitate the recollection of such events.
At Keen Eye, we target to deliver high-quality products in the most responsive way. Our ISO 13485 certification demonstrates this natural dedication to quality and the robustness of our quality management system.
Any clinical investigation needs to be conducted and managed with a strict compliance to regulation, using the most qualified tools and management. Our platform is dedicated to generate quantitative image analysis data in accordance with GCP and GLP principles.
To make sure you can trust your data, controls are in place to ensure that data is complete. The activities are documented timely and are attributable to a specific individual. Only authorized persons can make changes to records, with no overwriting. Records are regularly reviewed. Data are maintained securely from its creation to disposal.
Quality is involved in our daily activities, from the early steps of the projects. Our facilities, working environment and processes are controlled by standardised policies and procedures, which are reviewed regularly. We use an EDMS (Electronic Document Management System) to control our quality documentation, including records and enforce the records retention policy.
At Keen Eye, we are committed to have a strong clinical conscientiousness. In order to ensure the patient well being and safety each Keen Eye member is trained to the GCP and GLP regulations with a regular awareness and is qualified for its respective clinical and nonclinical project duties.
All software tools we use as part of the GCP and GLP processes, including the Keen Eye AI platform, are validated prior to use, in conformance with the industry standards. There are the two layers of validation for the platform : design qualification product-wise and IQ/OQ/PQ project-wise. Backups and contingency plans are in place to ensure business continuity.
By Charlotte Plestant (Scientific Content Manager), Shanyate Simonin (QARA Manager) - 31 Aug 2021
Life Science industry is among the most heavily regulated industries in the world. This regulatory environment is continuously changing in response to the introduction of new technologies, the increasing complexity of disease targets and the rising demands of both patients and regulators. We caught up with our QARA Manager Shanyate Simonin to discuss how Keen Eye deploys innovative deep learning technology within such a regulated industry.