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Know why each released change exists

Connect approved need, affected design, implementation, verification and release in one reviewable change chain.

Axiotech structures traceability and change evidence so reviewers can see coverage, impact, versions, exceptions and authority without relying on a spreadsheet that is manually repaired before an audit.

Good fit

Use this service when

  • Quality-managed or regulated automation and industrial software lifecycles.
  • OEM platforms with variants, installed-base releases and customer-specific changes.

Scope boundary

Not assumed or silently included

  • Generating trace links mechanically without competent review of meaning and coverage.
  • Treating source-control commits alone as approval, validation or production-release evidence.

Why act

The operational risk behind the technical symptom

The first work package is shaped around reducing an explicit risk or enabling a named decision.

01

Untraced requirements are missed, while unnecessary tests consume limited shutdown time.

02

Changes fix one machine but are lost, overwritten or incorrectly propagated to another.

03

Reviewers cannot distinguish an approved gap from an accidental omission.

Purchasable entry points

Choose a bounded engagement before expanding scope

Final inclusions, dependencies, location, schedule and commercial terms are confirmed in a formal quotation.

Package 1

Traceability health assessment

Decision enabled: A coverage and version-gap baseline with remediation priorities.

Typical scope: Identifier, document, source, test, release and deviation sampling plus risk review.

Package 2

Traceability implementation

Decision enabled: A maintainable requirement-to-evidence model embedded in delivery.

Typical scope: Schema, identifiers, repository/document links, workflow, migration, reports and training.

Package 3

Controlled change work package

Decision enabled: One change taken from impact assessment to approved evidence.

Typical scope: Request, impact/risk, design/source updates, verification, deviations, release and baseline reconciliation.

Artefact manifest

What remains after the engineering work

The exact document set scales with risk and the approved work package.

  • Requirement and evidence identification scheme
  • Impact and affected-item assessment
  • Bidirectional traceability matrix or controlled report
  • Change, review, test and deviation records
  • Approved release, baseline reconciliation and open-gap register

Technical and responsibility boundaries

Make ownership reviewable

  • Trace relationships express engineering meaning and require competent review.
  • Tool automation supports but does not replace risk, coverage and release decisions.
  • Emergency-change and field-service procedures must define later reconciliation and approval.

Review and acceptance

Six gates from authority to handover

Gate depth changes with the work; named decisions and evidence remain.

  1. G0
    Scope authorityOutcome, boundaries, roles, assumptions and commercial basis agreed.
  2. G1
    Baseline acceptedKnown installed/source state, dependencies, constraints and unknowns recorded.
  3. G2
    Design approvedRequirements, interfaces, risks and acceptance evidence ready for implementation.
  4. G3
    Release candidateBuild reviewed, verified, versioned and accompanied by defect disposition.
  5. G4
    Site acceptanceCommissioning evidence, deviations and release decision recorded.
  6. G5
    Handover acceptedSource, configuration, records, recovery and residual risks transferred.

Read the complete delivery method

Assurance option

Compliance is a declared scope—not a badge

Traceability demonstrates planned relationships and coverage; it does not itself prove correctness. The customer quality system determines required approvals, electronic-record controls, segregation and retention.

Review validation services

Relevant engineering evidence

Requirement-to-release traceability model

A tool-neutral demonstrator connecting requirements, risks, design items, source/configuration, tests, deviations and released versions.

Review this evidence

Procurement FAQ

Questions to resolve before quotation

Must traceability be stored in one tool?

No. The identifiers, controlled versions and report generation must remain reliable across the selected repository and document systems.

Can existing matrices be repaired?

Yes, but links are sampled against actual approved records and implementation; missing evidence is recorded rather than fabricated.

How are emergency changes handled?

The procedure should constrain authority and scope, capture the intervention, and require later risk, source, test and baseline reconciliation.

Next decision

Describe the outcome, installed baseline and constraints you already know.

Use “Not known” where evidence is missing. The first review will separate facts, assumptions and discovery work.

Scope Requirements traceability and software change control