Compliance and standards

Compliance evidence is built into every record, signature, and certificate.

CalBrix is structured so the operational workflow and the audit story are the same thing. Teams do not need separate systems for traceability, approval evidence, uncertainty support, and certificate output.

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ISO/IEC 17025ISO 9001GUM uncertaintyFDA 21 CFR Part 11IATF 16949AS9100DNIST-traceable

Frameworks mapped

Coverage for lab accreditation, quality management, electronic records, and uncertainty requirements.

Trail integrity

Hash-chained

Cryptographic audit history makes tampering detectable and reviewable.

Record posture

Audit-ready

Execution data, approvals, certificates, and evidence packages remain linked.

Standards coverage

Mapped requirements with the operational controls behind them.

Each standards block below shows how CalBrix translates compliance language into system behavior, record structure, and workflow controls your teams can actually use.

Standards mapping

ISO/IEC 17025:2017

General Requirements for Competence of Testing & Calibration Laboratories

The gold standard for calibration laboratory accreditation. CalBrix is designed from the ground up for ISO/IEC 17025 compliance, covering everything from measurement traceability to uncertainty estimation.

6.2

Personnel

Training records with competency assessments, skill matrices, and expiry tracking.

6.3

Facilities & Conditions

Environmental monitoring integration for temperature, humidity, and pressure with alerting.

6.4

Equipment

Asset register with calibration status, traceability chains, criticality ratings, and unique identification.

6.5

Metrological Traceability

NMI-anchored traceability (NIST, NPL, PTB, and other signatories of the CIPM MRA) flowing through lab reference standards to each UUT, with chain visualization and validation.

7.2

Selection & Verification

Procedure-driven calibration execution with measurement method documentation.

7.6

Measurement Uncertainty

Uncertainty budget calculator designed around GUM (JCGM 100:2008) principles, with propagation and contribution analysis.

7.8

Reporting Results

Calibration certificates with required statements, measurement results, and uncertainty.

8.2

Management System

Document control, audit trails, non-conformance management, and CAPA workflows.

Standards mapping

ISO 9001:2015

Quality Management Systems

CalBrix supports ISO 9001 Section 7.1.5 requirements for monitoring and measuring resources. Demonstrate that your instruments are suitable for their intended purpose with proper calibration records.

7.1.5.1

General

Evidence that monitoring and measuring resources are suitable and maintained.

7.1.5.2

Measurement Traceability

Traceable calibration against international or national standards (NIST, NPL, and other recognized NMIs). Identification of calibration status.

7.5

Documented Information

Controlled calibration records with version management, retention policies, and access controls.

10.2

Nonconformity & Corrective Action

NC and CAPA management for out-of-tolerance findings with root cause analysis.

Standards mapping

FDA 21 CFR Part 11

Electronic Records and Electronic Signatures

For organizations that need electronic record and electronic signature controls. CalBrix provides the documentation framework that regulated environments demand.

11.10(a)

System Validation

Architecture designed to support your IQ, OQ, and PQ validation process.

11.10(b)

Record Copies

PDF and DCC export of all calibration records for accurate and complete copies.

11.10(c)

Record Protection

Role-based access control, database encryption, and cryptographic hash chain audit trails.

11.10(d)

Limited Access

MFA, SSO, and role-based permissions restricting system access to authorized individuals.

11.10(e)

Audit Trails

Time-stamped, operator-identified, tamper-evident audit trails for all record changes.

11.50

Signature Manifestation

Electronic signatures display printed name, date and time, and meaning of signing.

11.100

General Requirements

Electronic signatures are unique to one individual and not reused or reassigned.

Standards mapping

IATF 16949:2016

Automotive Quality Management

CalBrix supports IATF 16949 calibration requirements including MSA studies, SPC monitoring, and gage management per AIAG core tool guidelines.

7.1.5.1.1

MSA

Integrated Gage R&R studies per AIAG MSA 4th Edition with EV, AV, GRR, PV, TV, and NDC calculations.

7.1.5.2.1

Calibration Records

Complete calibration records with reference standard identification and traceability.

9.1.1.1

SPC

Statistical process control charts with capability indices such as Cp, Cpk, Pp, and Ppk.

10.2.3

Problem Solving

Structured non-conformance handling with root cause analysis tools such as 5 Why and Fishbone.

Standards mapping

AS9100D

Aerospace Quality Management

CalBrix addresses the enhanced calibration requirements of AS9100D including risk-based calibration, configuration management, and full traceability.

7.1.5

Monitoring & Measuring Resources

Comprehensive instrument management with calibration status and traceability.

8.1.1

Operational Risk Management

Criticality-based calibration prioritization and risk scoring.

8.5.2

Identification & Traceability

Unique identification with QR labeling and complete calibration history.

10.2

Nonconformity

NC and CAPA management with impact assessment for out-of-tolerance events.

Standards mapping

GUM / JCGM 100:2008

Guide to the Expression of Uncertainty in Measurement

CalBrix includes a measurement uncertainty calculator built around GUM (JCGM 100:2008) principles, with support for Type A and Type B uncertainty evaluation, combined uncertainty, and expanded uncertainty.

Type A

Statistical Evaluation

Standard deviation of repeated measurements with degrees of freedom tracking.

Type B

Other Means

Uncertainty components from certificates, specifications, and prior knowledge.

Combined

Combined Standard Uncertainty

Root-sum-of-squares combination with sensitivity coefficient weighting.

Expanded

Expanded Uncertainty

Coverage factor-based uncertainty with configurable confidence levels.

Data integrity

A tamper-evident audit trail that holds up under review.

Every action in CalBrix is recorded in a cryptographically linked history. Reviewers can see who changed what, when it happened, and whether the sequence remains intact.

Cryptographic hash chain linking each audit event to the previous record
User identity, timestamp, action, and context stored for each event
Before and after values preserved for record changes and approvals
Exportable evidence set for auditor review and internal investigation
Tamper detection workflows to surface integrity issues quickly

Audit Trail

a3f8...e9c1CALIBRATION_CREATEDjsmith14:23:01

b7d2...4a1fMEASUREMENT_RECORDEDjsmith14:35:17

c1e5...8b3dRESULT_DETERMINEDjsmith14:42:33

d4f9...2c7eCERTIFICATE_GENERATEDjsmith14:43:01

e8a3...6d9bREVIEW_APPROVEDmjones15:10:22

f2b7...1e4cCERTIFICATE_SIGNEDmjones15:10:45

Chain integrity verified: 6 of 6 entries valid

Evidence package

The supporting controls around the standards map.

Beyond individual clauses, CalBrix gives regulated teams the surrounding record controls they need to defend process integrity over time.

Control area

Electronic signatures

Reviewer and approver actions stay attached to the record with signer identity, intent, and timing preserved.

Control area

Traceability records

Certificates, standards, environmental data, and execution evidence stay connected to the same calibration history.

Control area

Validation-ready controls

Role design, audit events, change history, and deployment model support regulated environments that need documented system behavior.

Audit preparation

Preparing for an audit or accreditation review?

We can walk your team through CalBrix from the perspective of traceability, approvals, record integrity, and standards evidence so you can evaluate it against your real audit posture.

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