PragmaSafe Integrated Safety Architecture
A unified lifecycle architecture for AI-enabled and regulated systems — from first concept to regulatory conformity.
Download PISA OverviewPISA integrates safety across the full product lifecycle. It begins where most safety approaches fail — at the definition of the acceptable residual risk boundary — and maintains coherence from architectural decisions through validation evidence, in-service monitoring, and conformity documentation.
We do not start from compliance. We start from engineering. Compliance is the outcome of building something safe — not a substitute for it.
Defines the safety concept, allocates risk to system components, and establishes the safety-critical architecture. This is where the safety boundary is declared and designed into the system structure.
Builds the evidence base. Scenario testing, dataset validation, test sufficiency assessment — all structured to support the safety claims made in the architectural domain. Evidence without claims is noise.
Monitors safety-relevant signals during operation. Post-deployment behaviour, field anomaly detection, and data collection feed back into the safety case — keeping it alive, not static.
Produces regulatory documentation that reflects engineering reality. Traceability matrices, technical files, risk management records — built on the substance of the preceding domains, not in parallel to them.
PISA begins with a declared residual risk boundary — everything else traces to it. Without this declaration, safety activities produce lists, not conclusions.
PISA is coherent across lifecycle domains — the same safety logic runs from design through operation and conformity. No silos. No disconnected artefacts.
PISA produces defensible evidence — not optimistic documentation. Every claim is traceable, every artefact is connected to the safety argument.
PISA is a patented methodology, developed from applied engineering experience in autonomous systems, MISRA standards work, and regulated product deployment across automotive, industrial, and AI-enabled domains.
The PISA Overview explains the four-domain architecture, the safety achievement conditions it operationalises, and how it applies to common regulatory contexts including ISO 26262, SOTIF, IEC 62304, and the EU AI Act.