Demonstration · Global Compliance · 3 steps
From a new market to an evidenced obligation register
Establish which obligations apply to a planned expansion, check the evidence for them, and see whether you will be ready by the audit date.
Example: Pellam Diagnostics Ltd (fictional) · Head of regulatory affairs. Fictional data and a scripted answer.
- What happened
- The company plans to sell in a new region and an external audit of its regulatory file is set for ten weeks from now.
- The question
- Which obligations apply to us there, how good is our evidence for them, and will we be ready in time?
The journey, step by step
Simulation. A scripted journey on fictional data, not produced by a live model. Each step uses what you decided in the steps before it, and only the figures are computed.
Which obligations applyAnswer questions about the plan. Each obligation applies, does not apply, or is undetermined until its questions are answered.Open
Answer questions about the plan. Each obligation applies, does not apply, or is undetermined until its questions are answered.
Answer the questions about the organisation. Each rule becomes applicable, not applicable, or undetermined until the questions it depends on are answered: nothing is assumed.
Obligation Where Status Evidence and owner Manufacturer registration
Synthetic Device Act, s. 4Region B UndeterminedNeeds: Will the company place the device on the market there itself None needed Clinical evaluation of software
Synthetic Device Act, s. 9Region B UndeterminedNeeds: Does the device include software that influences a clinical decision None needed Patient data localisation
Synthetic Data Code, art. 12Region B UndeterminedNeeds: Will patient data be processed in the region None needed Distributor due diligence
Synthetic Device Act, s. 6Region B UndeterminedNeeds: Will the company place the device on the market there itself None needed - Applies
- 0
- Does not apply
- 0
- Undetermined
- 4
- Answered
- 0 of 3
0 obligations apply, 0 do not, and 4 are undecided.
Each depends on facts about the plan [S1]; where a fact is not yet given the obligation is undetermined and nothing is assumed. For those that apply the register names the evidence and owner: 0 evidence items, 0 owners.
Relies on: S1 · Obligation library, regional extract
The head of regulatory affairs decides. Approving records the applicable obligations as the basis for the evidence review. It does not file anything.
Not ready. 4 obligations are undetermined until the questions they depend on are answered. Answer them first; nothing is assumed.
Next: How good is the evidence. It opens when the step above is complete.
Limits of this example
- Synthetic obligations; a real analysis uses the legal text.
- A scripted journey: no regulator was contacted.
- This is a scripted demonstration on fictional data. No model was called and no real organisation, person or result is shown.
The capabilities this draws on
- Regulatory Applicability IntelligenceWork out which obligations may apply to this business from its legal entities, activities, industry, locations, workforce and other verified facts, and show each as appl…
- Audit Readiness and Evidence CompletenessConnect each obligation to its controls, evidence, owner and effectiveness, show which artifacts are missing, and produce an evidence-backed preparation and gap report.
- Assurance and evidenceWhen an auditor or an inspector arrives, evidence has to be found in a hurry, and gaps appear for the first time.
The Global Compliance story · All demonstrations
The other journeys
- From a recording to a verified practitionerA line changeover is captured with consent, drafted from its sources, reviewed, released with its gates, and checked in practice.
- Finding and understanding your data, read onlyApprove which folders the platform may read, classify what a database holds, and see what depends on each source.
- From supplier findings to a recovery planReview invoice findings against contract terms, see what recovering them is worth, and decide whom to approach first.
- From a legal notice to a reviewed responseRead a letter before action, protect the evidence it asks you to keep, and settle the wording of the reply.
- From a what-if to a board resolutionTest an acquisition under assumptions, compare the options, and settle the resolution put to the board.
- From what the AI may read to answers with evidenceSet what an assistant may read, audit who has access, answer a customer's security questions with evidence, and check what the Trust area can honestly say.