Laboratory evaluation context
ISO/IEC 17025
ISO/IEC 17025 addresses the competence of testing and calibration laboratories. CalBrix record fields and a PDF demonstration do not establish laboratory accreditation or compliant certificate content.
- Validate methods, reference standards, traceability, uncertainty, decision rules and reporting with qualified personnel.
- The demonstration used synthetic readings and no physical instrument.
- Competency assessment, independent review controls and complete evidence workflows remain to be validated.
ISO: ISO/IEC 17025:2017No software certification claim
ISO 9001
Instrument records and quality workflows may be relevant to a customer's quality system. CalBrix does not establish compliance with that system or guarantee an audit outcome.
- One synthetic NC/CAPA lifecycle was tested.
- Due-date/status inconsistencies must be resolved before relying on recall or quality reports.
- Define the records, responsibilities and validation evidence required for your implementation.
Not validated for regulated reliance
FDA 21 CFR Part 11
A password-verified signature was demonstrated; this alone does not demonstrate Part 11 compliance. Deployment-specific validation, access controls, record integrity, retention and signature requirements require assessment.
- Independent performer/reviewer roles, account recovery, MFA and SSO were not comprehensively tested.
- Historical audit verification mismatches remain.
- PDF test output is not a claim of complete record-copying or DCC capability.
FDA: Part 11 scope and application guidanceIndependent validation required
Uncertainty and decision rules
Uncertainty, guard banding, coverage factors and decision-rule tools have not received a complete method-validation pass. No validated conformance with GUM or Z540.3, or traceability to NIST, is claimed.
- A tolerance check in a synthetic worksheet is not full uncertainty evaluation.
- Reference traceability must be supported by actual records and valid standards.
- Do not issue operational results from unvalidated calculations.
Selected examples only
Automotive quality and MSA
One range-method Gage R&R study and a selected SPC example were tested with synthetic data. This is not complete AIAG-method validation or IATF 16949 compliance.
- Verify formulas, inputs, limits, edge cases and intended interpretation independently.
- No process-capability or equipment-qualification claim follows from a synthetic test.
Suitability not established
Aerospace and other regulated environments
Industry references are possible evaluation contexts, not validated coverage. CalBrix does not claim aerospace, nuclear, hazardous-area or safety-critical operational approval.
- Review each specific standard and operational requirement with qualified personnel.
- Do not infer approved risk, configuration or traceability controls from a feature description.
Known integrity limitation
Audit history
Selected new entries passed verification, but ten historical entries have unresolved mismatches. No live chain-integrity badge or universally immutable record claim is made.
- Historical records were retained rather than silently rehashed.
- Resolve integrity and authorization requirements before regulated use.
Evaluate the fit before operational use.
Use synthetic data first. Production use depends on resolving relevant gaps, validating your procedures and controls, and agreeing acceptance and commercial terms. A demo does not establish metrological validity, compliance or security certification.