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Governance, Compliance & Quality Assurance

Regulatory compliance

We support companies in bringing their systems and processes into line with the obligations that apply to them: reading the standard, gaps, evidence and audit.

EN UNE PHRASE

Compliance is demonstrated on your real set-up.

THE PROBLEM

The situations that bring us in

  • 01

    The supplier's attestation is taken for the compliance of the set-up actually in service.

  • 02

    The requirements of the standard have never been turned into operational obligations.

  • 03

    The documentation exists but the evidence of application is missing.

  • 04

    Identified gaps are not tracked through to closure.

  1. 01THE PROBLEM

    A regulatory obligation to meet, with no operational reading of the requirements and no body of evidence assembled.

  2. 02WHAT AXENEO DOES

    We analyse the applicable standard, run the gap analysis, formalise processes and procedures, assemble the evidence and track the remediation plans through to audit, where certification is required.

  3. 03THE RESULT

    A coherent documentation file, gaps addressed and tracked, and teams prepared for their exchanges with the certifying body.

What we do

Diagnose

  • Analysis of the requirements of the applicable standard
  • Translation into operational obligations
  • Gap analysis and rating of the gaps
  • Analysis of the interfaces and the customisations

Bring into compliance

  • Formalisation of the processes and the procedures
  • Assembly of the documentation file and the evidence
  • Remediation plans and action tracking
  • Audit preparation and compliance reviews
  • Periodic review of operational compliance

The Governance, Compliance & Quality Assurance method

This domain sits within the pillar’s overall method.
  1. 01

    Scoping

    Quality enters the project with the scoping: requirements formalised, testable, prioritised and linked to an identified need.

  2. 02

    Requirements

    Every requirement gets an owner, an acceptance criterion and a link to the test that will verify it. Traceability is built as you go, not reconstructed afterwards.

  3. 03

    Quality plan

    Roles, expected deliverables, reviews, quality gates and go-live conditions. The setup is sized to what the programme is worth.

  4. 04

    Testing

    Test strategy by level, coverage reported against requirements, representative data sets and controlled environments.

  5. 05

    Validation

    Functional validation, integration, regression. Gaps are qualified and settled in governance, not absorbed quietly.

  6. 06

    Compliance

    Where a standard applies, the body of evidence and the remediation plans are built continuously, through to the audit.

USE CASES

Where we step in

  • Application certification standard

    Check that the version deployed, its configuration, its interfaces and its archiving genuinely meet the requirements of the standard.

  • Sustaining compliance

    After a migration, a change of supplier or a version upgrade: reassess compliance.

Contact

Regulatory compliance: let’s talk about your context

Whether the subject is a programme to secure, an acceptance process to structure or a certification to prepare, the first question is the same: what exactly are we committing to, and how do we demonstrate it?