In accordance with 21 CFR Part 11 there are a range of features that organizations are required to have in place when implementing a computer system to manage electronic records and processes. Assurances for audit trail functionality, electronic signatures, security and data integrity, records retention and file formats are to name but a few. Periodic user access reviews will help to identify accounts that have been assigned excessive privileges, accounts with access that have not been updated to reflect job position changes, and dormant accounts. Failing to perform user access reviews on a regular basis will place the organization n at a higher risk for:
SecurEnds helps comply with Part 11 to limit user access and their privileges by automating the certification process for organization
Manage the discovery of identities across connected and disconnected applications across the IT landscape. Match identities to the system of record. Use CSV upload, Pre-build Connectors, FlexConnectors, and Service Desk integration. Integrates with ITSM system(ServiceNow, JIRA, etc) to update the changes.
Centralize access controls and consolidate identity repositories. Powered by artificial intelligence and machine learning, Discovery Module enables auto-discovery of identities, including orphaned and unauthorized accounts.
Schedule automated access review campaigns by multiple dimensions (roles etc). Call to action intelligent reminders for end-users, approvers and skip level approvers. “Delta Campaign”, a quick snap campaign, allows you to see the changes since the last review.
Our AI/ML module presents a simplified analytics workflow for outliers based on their risk profiles and excessive privileges. Drill down by campaigns, applications and periods.