REGULATED INDUSTRIAL DATA
Technical controls supporting
EU GMP Annex 11
Evaluating software for GMP-regulated operations? See how TDengine TSDB-Enterprise and IDMP contribute to key Annex 11 requirements for data storage, audit trails, change control and security.
TDengine TSDB-Enterprise
TDengine IDMP
*Technical controls support a customer validation project. Product features alone do not establish Annex 11 compliance or certify a deployment.
What Annex 11 Requires & How TDengine Supports It
Four important areas from the technical guide, presented side by side with relevant TDengine controls.
Each deployment still needs configuration and qualification for its intended GMP use.
Data Storage
Electronic records need protection throughout retention, with suitable backup arrangements and checks that data can be restored.
TDengine TSDB supports configurable data retention and backup/recovery options. IDMP has documented backup and restore capabilities for its own components.
What to verify: Set retention for each record type and test recovery of data, audit history and required dependencies.
Audit Trails
GMP-relevant changes and deletions should be traceable, including reasons where required, and audit information should be available for review.
IDMP provides audit records for covered objects. Historical measurement corrections retain previous and updated values, actor, sample/edit times and reason. TSDB audit settings require separate assessment.
What to verify: Confirm every approved correction path, audit coverage, retention and complete reviewable exports.
Change Control
Changes to a computerised system should be managed through a controlled process, with documented review and approval appropriate to the change.
IDMP supports version history, Git-based configuration comparison and review, controlled publishing and published-version rollback for covered configuration.
What to verify: Retain change approvals, release records and regression evidence for the full system, including interfaces and infrastructure.
Security
Access should be restricted to authorised personnel, with appropriate controls and attribution of significant actions.
IDMP supports individual users, roles, site-scoped permissions and enterprise identity integration. TSDB Enterprise provides configurable database permissions and audit features.
What to verify: Test permitted and prohibited access across the UI, APIs, database accounts and service accounts.
*These summaries are shortened descriptions, not the full regulatory wording or a declaration that every Annex 11 clause is satisfied.
The full technical guide maps the Annex 11 Principle and Sections 1–17 and identifies qualifications and open items.
How TDengine Fits into a GMP-Regulated Data Environment
See how plant data sources, TDengine TSDB, and TDengine IDMP can work together with access controls, audit evidence,
and recovery processes in a regulated manufacturing environment.
ENTERPRISE IDENTITY
Named users · roles · SSO
QUALIFIED TIME SOURCES
Time sync · clock drift monitoring
QUALITY / VALIDATION
URS · approved tests · SOPs
Plant data sources
PLCs · SCADA · instruments
Collectors / middleware
Defined interface checks
TDengine TSDB
Time-series records
Database access and audit
Configured retention
TDengine IDMP
Asset models and views
Controlled configuration
Audit review and export
Reviewed evidence
Record copies · reports
Approved procedures
Release authorization
Protected recovery & retained evidence
TSDB + IDMP backups · audit and Git evidence · restore and archive verification · credentials and keys
*Logical responsibilities only. Deployment boundaries, ownership and recovery depend on the validated installation.
Explore the Evidence Behind the Controls
Get the detailed assessment of TDengine TSDB-Enterprise and IDMP for EU GMP Annex 11-regulated pharmaceutical manufacturing environments.
Annex 11 Principle and Sections 1–17 requirements mapping
Technical controls for pharmaceutical data integrity, audit trails, security and recovery
GAMP 5 validation approach, proposed qualification tests and customer responsibilities
Known limitations and items requiring release-specific confirmation
*This document does not constitute certification or executed validation evidence.
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 GuideCommon Questions
Key qualifications to clarify before incorporating the platform into a regulated GMP system.
No. TDengine provides supporting technical controls. The regulated organization must validate its complete system, including intended use, infrastructure, configuration, processes, training, and operating responsibilities.
No. It proposes validation deliverables and evaluation scenarios. Supplier documentation, test reuse, IQ/OQ/PQ execution services and approval responsibilities must be agreed for a specific project.
GPG-signed configuration commits are documented. Regulated record-signing and qualified-person batch-certification workflows beyond that scope require separate assessment and system-level validation.
Manual data entry is supported, but the guide does not establish a validated second-person or equivalent accuracy-check workflow for critical entries. That control must be defined and tested for the intended use.
No. The actual TSDB and IDMP release, license edition, security baseline, audit configuration and integrated components must be documented and qualified. IDMP System Log should be enabled before regulated operation.
Evaluating TDengine for a GMP-regulated system?
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