REGULATED INDUSTRIAL DATA
Technical controls supporting
21 CFR Part 11
Evaluate the controls behind your industrial data. Explore how TDengine supports traceability, controlled access, and record protection in a Part 11-governed system.
TDengine TSDB-Enterprise
TDengine IDMP
Control matrix, requirements mapping, and evaluation guidance in one document.
*Technical controls are one part of compliance. Compliance depends on your complete validated system, intended use, configuration, infrastructure, procedures, and training.
Evaluate the Controls Your Records Depend On
Documented capabilities across TDengine TSDB-Enterprise and IDMP.
Confirm the release, license, and configuration for your intended use.
Audit trails & traceability
Capture who changed what, when, and why. Review before-and-after details and export audit records.
Enable audit logging before use. Written IDMP audit records cannot be edited or deleted through the application.
Watch introduction videoIdentity & access
Apply individual accounts, role-based permissions, and site boundaries. Integrate enterprise identity and step-up MFA.
Configure and validate roles, identity integrations, and which operations require additional verification.
Watch introduction videoControlled changes
Track configuration history, review proposed changes, and publish approved versions through governed workflows.
Documented GPG signatures cover version-controlled IDMP configuration and model commits.
Watch introduction videoRecord retention & retrieval
Use UTC timestamps, configurable retention, archive storage, and retrieval tools to support access to historical records.
Validate record-copy completeness and retention. Trusted time synchronization is managed in your infrastructure.
Watch introduction videoSecurity & recovery
Configure encryption, TLS, backups, point-in-time recovery, high availability, and disaster recovery for your deployment.
Capabilities depend on edition and configuration. Test restoration, failover, and recovery against your requirements.
Watch introduction videoPreserve Site Boundaries. Govern Shared Visibility
Plan how data, identities, and infrastructure work together across your system.
Manufacturing site 1
Plant data sources
Local TDengine / isolated database
Manufacturing site 2
Plant data sources
Local TDengine / isolated database
Manufacturing site 3
Plant data sources
Local TDengine / isolated database
Controlled central visibility
Approved synchronization or governed queries · Reporting · Retained audit history
Enterprise identity and access
Customer-managed time sources
Retention, backup, and recovery
*Illustrative deployment pattern. Physical and logical separation require different design and validation decisions.
Connect Each Requirement to Evidence
Start with the product contribution. Then define the configuration, tests, and operating procedures your system needs.
| Part 11 requirement | TDengine contribution | Evaluation boundary |
|---|---|---|
| §11.10(d) · Limited access | Accounts, roles, site boundaries, and authentication | Available with configuration |
| §11.10(e) · Audit trails | Attributable, time-stamped audit records and change details | Available with configuration |
| §11.10(c) · Record protection | Retention, archive storage, backup, and recovery | Available with configuration |
| §11.50 / §11.70 · Signatures | GPG signatures linked to configuration commits | Scope confirmation required |
Selected examples, not a complete compliance assessment.
Read the full mappingWhat TDengine contributes
Documented technical capabilities for access, audit, configuration control, record protection, and recovery that can be tested within your system.
What your organization establishes
Intended use, applicable record requirements, validated configuration, connected-system controls, SOPs, training, and ongoing review.
Take a Closer Look at the Evidence
Watch the overview, then use the guide to structure your technical evaluation.
How TDengine supports regulated data environments
Video overview · Pharmaceutical manufacturing context
See the controls explained
A walkthrough of auditability, identity, authentication, record protection, and recovery, with the complete-system compliance boundary explained.
Technical Controls Supporting 21 CFR Part 11
Version 1.1 · September 2026 · 12 pages
Review the full technical guide
Explore the control matrix, requirements mapping, deployment considerations, limitations, and recommended evaluation and validation plan.
Download the Controls GuideBefore You Evaluate
No. TDengine provides supporting technical controls. Compliance depends on the complete validated system, including intended use, configuration, procedures, infrastructure, training, and operational controls.
No. Product release, edition, license, and configuration matter. IDMP audit logging must be enabled before use, and some interfaces require explicit TLS configuration. Confirm the baseline for your deployment.
No. The documented GPG workflow applies to version-controlled IDMP configuration and model commits. Batch release, alarm acknowledgement, and other regulated-record signatures require separate assessment.
The guide documents capabilities; it does not establish a complete customer validation package. Confirm available validation support and deliverables with TDengine for your specific project.
Bring Your Requirements. Start with the Documented Controls
Use the guide to identify product capabilities, configuration needs, and the evidence your evaluation should cover.
