Find the problems attributed to your regulation.
Each regulation below already has purpose-written problems behind it: the obligation, the evidence it demands, and what most organisations cannot yet produce when asked.
Cross-regulatory compliance and audit readiness
Most organisations are not working against one regulation. They are working against several at once, each with its own auditor, its own evidence format and its own definition of what counts as proof. IGX360 Insights gives every framework a shared, defensible view of how the business actually operates, so evidence does not have to be rebuilt from scratch each time a different regulator asks the same underlying question.
4 problemsDORA
DORA requires financial entities to maintain a register of ICT third-party arrangements and to demonstrate that ICT risk is managed end to end, not just documented. Most firms can produce the register. Far fewer can show, process by process, how an ICT incident at a named third party actually propagates through the operations that depend on it. IGX360 Insights connects the register to the operating model it is supposed to describe.
9 problemsFCA/PRA operational resilience
The FCA/PRA operational resilience regime asks firms to set impact tolerances for their important business services and to prove, not assert, that those tolerances would hold under a severe disruption. That proof depends on knowing exactly which processes, systems and third parties sit behind each important business service. IGX360 Insights makes that dependency chain visible and testable, rather than reconstructed by hand before each self-assessment.
7 problemsEU AI Act
The EU AI Act's duties attach to specific uses of AI within a process, not to AI in the abstract. Meeting them means knowing which process an AI system operates inside, who is accountable for its decisions and what evidence exists if that decision is later questioned. IGX360 Insights operationalises those duties directly against the operating model, so agentic AI is deployed where authority and accountability are already defined, not layered on top of a process nobody can fully describe.
12 problemsFDA QMSR
The FDA's Quality Management System Regulation aligns US medical device quality requirements with ISO 13485, and with that shift comes a harder question: does the documented quality system actually match how devices are designed, manufactured and tracked day to day? IGX360 Insights closes that gap, reconciling the documented process against the operational reality FDA inspectors and QMSR audits are testing.
10 problemsEMA / EU medicines and GxP
GxP inspectors do not audit the procedure manual. They audit whether the process described in it is the process actually followed, batch after batch, site after site. IGX360 Insights gives pharmaceutical and biotechnology organisations a live, evidenced view of that alignment, so an EMA or national competent authority inspection is not the first time the gap between documented and actual practice gets found.
10 problemsUK Telecommunications Security Act
The UK Telecommunications (Security) Act 2021 places specific security duties on public telecoms providers, enforced through Ofcom's code of practice, that go beyond generic cyber hygiene into how network operations, supply chain and incident response are actually governed. IGX360 Insights traces those duties through to the processes that carry them out, so a security obligation is not just a policy statement sitting apart from network operations.
9 problemsNIS / NIS2
NIS2 widens who counts as an essential or important entity and tightens what has to be reported, and how fast, when an incident occurs. Meeting that timeline depends on already knowing which processes an affected system supports and who owns them, not working it out after the incident has started. IGX360 Insights keeps that dependency map current, so the clock NIS2 starts is one the organisation can actually meet.
8 problemsAviation safety management
A safety management system is only as strong as its connection to daily operations. Where the documented procedure and the practice on the ground have quietly diverged, that divergence is exactly what an SMS is supposed to catch, and exactly what most organisations cannot see until an audit or an occurrence forces the question. IGX360 Insights keeps the operational picture current against the documented safety case, not reconciled once a year.
10 problemsEnergy cyber resilience
Energy and utilities operators sit inside critical national infrastructure obligations that treat cyber resilience as an operational, not purely IT, requirement: a failure has to be traced through to the business services it would actually disrupt. IGX360 Insights maps that chain from system to process to service, so resilience testing is grounded in how the operator really runs, not a generic control inventory.
8 problemsData protection and privacy
Data protection obligations are usually mapped to systems and data flows, but the accountability question underneath them is a process question: who decided this data would be collected, who can change that decision, and what happens when an AI system starts acting on it. IGX360 Insights connects the data map back to the process and the decision-maker behind it, so accountability survives contact with an audit.
10 problems