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Axiotech Automation Ltd
+44 (0)7415 112 892
sales@axiotech.co.uk

Risk-based lifecycle evidence

Build validation evidence with the automation system instead of reconstructing it at the end.

Axiotech supports automation suppliers and regulated organisations with intended-use, risk, requirements, design, source/configuration, traceability, verification and change evidence aligned to the customer quality system.

Scope this requirement See all validation & compliance

Good fit

Use this service when

  • PLC, HMI, SCADA, data-interface and industrial software work requiring risk-based supplier evidence.
  • Regulated customers or OEMs needing a defined engineering contribution to their validation lifecycle.

Scope boundary

Not assumed or silently included

  • Claiming that GAMP 5 is a product certification or that Axiotech alone validates the customer system.
  • Approving intended use, quality risk, validation acceptance or production release on behalf of the regulated organisation unless formally authorised.

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

Documentation produced after coding does not explain or control the decisions actually made.

02

Every requirement is tested equally while critical risks and interfaces receive insufficient attention.

03

Supplier evidence, customer protocols and approved source/configuration drift apart during change.

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

Validation-readiness assessment

Decision enabled: A classified gap register and proportionate remediation path.

Typical scope: Intended use, system boundary, roles, lifecycle records, source/configuration, traceability and evidence review.

Package 2

Lifecycle documentation work package

Decision enabled: Approved engineering documents connected to implementation and verification.

Typical scope: Plan inputs, requirements, design, risk, traceability, review, test and release records as scoped.

Package 3

Validated change support

Decision enabled: A controlled impact, implementation, verification and release evidence set.

Typical scope: Change assessment, affected requirements/design, version baseline, risk-based tests, deviations and handover.

Artefact manifest

What remains after the engineering work

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

  • Intended-use, boundary and supplier-responsibility record
  • Risk-based requirement and design specifications
  • Configuration/source baseline and traceability matrix
  • Review, test, deviation and defect evidence
  • Release approval input, residual risk and lifecycle handover

Technical and responsibility boundaries

Make ownership reviewable

  • The regulated organisation owns intended use, validation strategy, quality-risk acceptance and final release.
  • Axiotech authors or supports only the documents and engineering evidence named in its responsibility matrix.
  • Procedures, training, infrastructure and operational controls outside the technical scope remain customer responsibilities.

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

“GAMP 5-aligned” describes a risk-based engineering approach, not certification or an automatic compliance conclusion. Applicable laws, regulations, guidance, customer procedures and system criticality must be determined for the specific intended use.

Review validation services

Relevant engineering evidence

GAMP 5-aligned automation evidence chain

A reference structure linking intended use, quality risk, requirements, design, versioned implementation, verification, deviations and release authority.

Review this evidence

Procurement FAQ

Questions to resolve before quotation

Does Axiotech validate the system?

Axiotech can supply scoped engineering and verification evidence. The regulated organisation retains validation ownership and decides fitness for intended use.

Must every project produce the same documents?

No. The document and verification set should be proportionate to intended use, risk, novelty, complexity, supplier capability and customer procedure.

Can you remediate an existing system?

Yes. Remediation begins with current evidence and risk, then separates recoverable facts, retrospective justification, required testing and procedural actions.

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 GAMP 5-aligned automation engineering