Standards Alignment
Designed to support regulated and evidence-sensitive workflows
TARE helps teams produce clearer records, stronger provenance, better audit evidence, and more reviewable documentation for teams preparing audit-ready lab records.
Designed to support 21 CFR Part 11 concepts
Designed to support GxP-style documentation practices
Designed to support ISO/IEC 17025-style evidence expectations
Supports data integrity principles such as attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available
21 CFR Part 11 concepts
- Reviewable records with attributable operators
- Tamper-evident audit trail primitives
- Signed export bundles and record linkage
- Access controls and human-reviewed changes
GxP-style documentation practices
- Structured experiment and session records
- Attachments, review, and revision visibility
- Controlled documentation around samples and materials
- Clearer evidence assembly for audit preparation
ISO/IEC 17025-style evidence expectations
- Sample and material context
- Custody-relevant event capture
- Evidence references tied to records
- Signed export bundles designed to support defensible records
| Control | Rationale | Part 11 | GxP-style | ISO/IEC 17025-style |
|---|---|---|---|---|
| Attributable operator actions | Link record activity to the responsible operator and workspace. | Supported | Supported | Supported |
| Tamper-evident audit trail | Retain reviewable event history across documentation changes and workflow state. | Supported | Supported | Supported |
| Evidence attachment integrity | Preserve evidence references with integrity checks and traceable linkage. | Supported | Supported | Supported |
| Signed export bundle | Export reviewable records, evidence references, and timeline context together. | Supported | Supported | Supported |
| AI suggestions under human approval | Keep human review authoritative for documentation and state changes. | Supported | Supported | Supported |