PISA

PragmaSafe Integrated Safety Architecture


A unified lifecycle architecture for AI-enabled and regulated systems — from first concept to regulatory conformity.

Download PISA Overview

Safety requires architecture, not just activity


PISA 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.

Four integrated lifecycle domains


Architectural Safety

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.

Validation Safety

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.

In-Service Safety

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.

Conformity Safety

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.

What makes PISA different


1

PISA begins with a declared residual risk boundary — everything else traces to it. Without this declaration, safety activities produce lists, not conclusions.

2

PISA is coherent across lifecycle domains — the same safety logic runs from design through operation and conformity. No silos. No disconnected artefacts.

3

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.

Read the PISA Overview


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.