Our most secure and compliant digital pathology platform

  • April 16th 2024
  • in
PathcoreFlow 3.4

Large-scale adoption of digital pathology in FDA-regulated industries has long been challenging because of limited vendor support for software system validation, exportable audit trails and other technical controls required by 21 CFR Part 11 regulations.

Today, we are thrilled to announce that the new features launched with version 3.4, PathcoreFlow can be broadly used in regulated pre-clinical workflows that are subject to the FDA’s Part 11 regulations for processing electronic data. These improvements, coupled with Pathcore’s ISO 27001 certified information security management system (ISMS) and a host of other security features, elevate PathcoreFlow as the most secure and compliant digital pathology platform for preclinical research.

Learn about the benefits of PathcoreFlow

Title 21 CFR Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs and other FDA-regulated industries. This regulation requires the implementation of technical controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data.

Version 3.4 comprises 151 completed issues, leading to major and minor improvements. Security and compliance are major themes in 3.4, with several new features that specifically address the FDA’s requirements for processing electronic records under 21 CFR Part 11. With these improvements, it’s much easier to incorporate PathcoreFlow in GLP/GCP regulated environments. These new features include:

  • SAML single sign-on (SSO) adds to our existing LDAP capabilities for identity management and access control. This new feature is great for compliance and security while simplifying users' login processes. 

  • IQ/OQ/PQ reporting is now available, to support computer system validation for Part 11 compliant processes that incorporate PathcoreFlow

  • Dedicated validation environments for acceptance testing of new and updated version of the software

  • An activity feed in the repository that captures changes to data. This new feature complements existing capabilities for exportable audit trails and reason for change tracking.

Along with a long list of other improvements that address customer-reported issues and bugs, v3.4 elevates PathcoreFlow for use in regulated GxP environments.

Contact us to learn more about Pathcore Flow 3.4

Explore the detailed release notes to understand the new features and improvements that make this our most secure and compliant platform yet. Navigate here to dive deeper into the release notes.