STANDARDS ALIGNMENT // CONTROL MAPPING
TARE compliance posture across GLP, GMP, ISO 17025, and 21 CFR Part 11.
TARE is built for regulated operational environments where data integrity, attribution, and auditability are non-negotiable. This page maps platform capabilities to common control expectations used by quality, validation, and regulatory teams.
Standards coverage snapshot
Each standard below is supported through operational controls, evidentiary logging, and governance workflows in TARE.
GLPSupported Controls
Good Laboratory Practice
Supports attributable records, SOP-driven execution, and traceable study activities for regulated lab operations.
- Role-aware SOP and protocol workflows
- Attributable operator actions with evidence context
- Tamper-evident activity history for inspections
- Structured records across samples, instruments, and runs
GMPSupported Controls
Good Manufacturing Practice
Enables controlled execution, batch-adjacent traceability, and deviation visibility across process-critical actions.
- Controlled procedure execution and approvals
- Deviation and alert surfaces linked to telemetry
- Audit-ready event chains for critical actions
- Access control and duty-based permissions
ISO 17025Supported Controls
Testing and Calibration Competence
Supports calibration traceability, method discipline, and defensible technical records for quality systems.
- Calibration tracking and instrument trust posture
- Measurement history and event-level provenance
- Consistent record structures for verification activity
- Chain-of-custody support for samples and evidence
21 CFR Part 11Supported Controls
Electronic Records and Signatures
Delivers control primitives needed for high-assurance electronic records and compliant signature workflows.
- Attributable electronic signature workflows
- Access controls and session governance
- Computer-generated audit trails with integrity protections
- Signature-to-record linkage and forensic reviewability
Control domains and platform features
Identity and Access Control
- Role-based authorization for lab, compliance, and admin operations.
- Session governance patterns aligned to regulated workflows.
- MFA/passkey-capable authentication and attributable user context.
Electronic Records Integrity
- Tamper-evident event logging and audit correlation.
- Traceable action context across assets, samples, and protocols.
- Forensic exportability for internal and external review.
Procedure and Workflow Governance
- SOP/protocol workflows with validation and execution guardrails.
- Workflow graph integrity checks for production protocol design.
- Linked evidence trails for approval and execution decisions.
Calibration and Technical Traceability
- Calibration and instrument-state visibility in daily operations.
- Traceable links between measurements, devices, and operators.
- Support for inspection-ready metrology documentation.
Audit Readiness and Reporting
- Searchable compliance surfaces for rapid evidence assembly.
- Operational telemetry linked to governance actions.
- Control mapping views for readiness assessments.
Validation and Quality Enablement
- Supports quality teams performing IQ/OQ/PQ programs.
- Structured records for validation and change control packets.
- Clear evidence boundaries for legal and regulatory audit review.
21 CFR Part 11 mapping highlights
Part 11 is often the highest-bar requirement set for electronic records and signatures. TARE aligns platform controls to commonly audited sections.
| Part 11 Reference | Control Objective | TARE Support |
|---|---|---|
| 11.10(d) / 11.10(g) | Authorized access and identity accountability. | Permission-scoped route controls, attributable user context, and governed session behavior. |
| 11.10(e) | Secure, computer-generated, time-stamped audit trails. | Tamper-evident audit events and timeline reconstruction surfaces across regulated actions. |
| 11.50 / 11.70 | Signature manifestation and signature/record linkage. | Electronic signature workflows tied to records, with reviewable identity and action metadata. |
| 11.10(k) | Operational controls for system documentation and procedures. | SOP/protocol management, workflow validation checks, and traceable execution history. |