21 CFR Part 11 Electronic Record Controls
Telemetry2U provides structured electronic record workflows, secure time-stamped audit trails, and role-based electronic signature controls designed to support FDA 21 CFR Part 11 requirements within regulated environments.
Currently deployed within pharmaceutical manufacturing facilities, the platform enables controlled electronic records across connected devices and wireless sensors. Implementation validation and procedural compliance remain the responsibility of the deploying organisation.
Controlled Electronic Record Workflows
Telemetry2U enforces credential-based approvals and structured audit logging within a unified cloud-based IoT platform.
Platform-Level Enforcement Across the System
21 CFR-related controls are applied consistently across alerts, reports, device configuration, and administrative workflows.
Pre-Commit Confirmations
Configured actions require credential verification before modifications are saved.
Record Retention & Export
Audit events can be generated in human-readable and electronic formats suitable for inspection.
End-to-End Event Traceability
Authentication events, configuration changes, and electronic confirmations are permanently logged.
Need Clause-by-Clause Detail?
Review the full regulatory mapping of how Telemetry2U controls align with FDA 21 CFR Part 11 definitions.