Standards Guide
Designed to support Part 11-style control expectations.
TARE is designed to support controls relevant to electronic records, audit trails, electronic signatures, review workflows, and ISO/IEC 17025-style evidence expectations. Final validation depends on the customer workflow, SOPs, configuration, and regulated use case.
Relevant controls
Part 11-style reviews often focus on electronic records, audit trails, electronic signatures, access controls, record retention, and validation responsibility.
- Electronic records
- Audit trails
- Electronic signatures
- Access controls
- Review workflows
- Customer validation
What TARE does not certify
TARE does not make a customer workflow compliant by itself. SOPs, validation, training, configuration, and quality-system signoff remain customer responsibilities.