Quality & Software Validation
TraceGauge is developing an auditable quality and software-validation framework for regulated use. The controls below distinguish implemented product capabilities from evidence that still requires formal approval, execution and customer qualification.
Intended use
TraceGauge supports controlled records for tool inventory, custody, calibration/verification, procedures, reference standards, environmental conditions, OOT investigations, electronic approvals and certificates.
Boundary: the software records evidence and workflow. It does not itself establish measurement competence, SI traceability, laboratory accreditation, or conformity to an aerospace QMS.
Validation lifecycle
- Intended-use and requirements definition
- Risk assessment for product/QMS-impacting functions
- Requirements-to-test traceability
- Installation / operational / performance qualification or equivalent
- Defect, release and change control
- Regression testing and validation impact assessment
EVIDENCE PACK MUST BE EXECUTED
Electronic approvals
Production qualification should verify unique user identity, role authorization, signature meaning, timestamp, record locking, audit history and controlled revision behavior.
Certification status
Trace Gauge LLC does not claim AS9100, ISO 9001, ISO 27001, SOC 2 or ISO/IEC 17025 certification on this page. Any future certification will be published only with verifiable scope, certificate number and issuing body.