Agentic Compliance Suite: Compliance by Design with Deloitte and PTC

Software-defined products that meet the standard the first time. Deloitte’s governance agents run on the PTC product spine, so regulatory evidence is generated as engineering happens.
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Compliance is now an engineering problem

Products are becoming software-defined across every discrete manufacturing industry, and regulators have followed. Automotive programs answer to ASPICE, UN R155, ISO 26262 and NHTSA. Medical device makers work to FDA and EU MDR expectations. Aerospace and defense programs carry digital engineering mandates, and industrial and high-tech manufacturers face rising safety and cybersecurity obligations. The data to answer every regulator question already exists. It just lives in separate systems, and evidence is still assembled by hand, program by program. That gets expensive fast: 85% of lifecycle cost is committed early in a program, and a requirement error found in the field costs 10–100x more to fix than one caught at the requirements stage. The Agentic Compliance Suite from Deloitte and PTC moves compliance upstream, where it costs less to get right.

One regulator question shouldn’t take six teams to answer

A cybersecurity finding lands. Someone asks what it actually affects. Answering it means a requirements engineer in Codebeamer, a PLM architect in Windchill, a variant lead, a design engineer in Creo and a service team. Six teams. Several days. Evidence stitched together by hand. Hear Deloitte’s Stavros Stefanis on how software, data and AI are reshaping product innovation and regulatory complexity.

Meet the Deloitte Team
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Compliance questions cross every system. Answers live in each one.

Product-specific intelligence solves problems inside a product. Regulators, executives and customers ask questions that span all of them.

Product-specific intelligence solves problems inside a product. Regulators, executives and customers ask questions that span all of them.

Modern ALM Solutions

Evidence assembled by hand

Safety, cyber and process-conformity evidence is compiled manually from requirements, test and change records, program by program, and rebuilt for every audit.

Safety, cyber and process-conformity evidence is compiled manually from requirements, test and change records, program by program, and rebuilt for every audit.

Variants multiply the burden

Evidence is needed per variant, and copy-per-configuration spreadsheets can’t scale. Variant management is where software-defined programs quietly stall.

Evidence is needed per variant, and copy-per-configuration spreadsheets can’t scale. Variant management is where software-defined programs quietly stall. Learn About PLE

Change impact crosses every system

One change spans PLM, ERP, suppliers and the field. Impact analysis becomes an investigation instead of a query.

One change spans PLM, ERP, suppliers and the field. Impact analysis becomes an investigation instead of a query.

The field closes the loop

Over-the-air updates, field fixes and recalls need unit-level traceability and regulator-ready evidence long after the product ships.

Over-the-air updates, field fixes and recalls need unit-level traceability and regulator-ready evidence long after the product ships.

Automotive leads. Every discrete manufacturer benefits.

Wherever products are software-defined and regulated, the question is the same: what is affected, and can we prove it? Start where the pressure is highest, then scale the same governed thread across your portfolio.

Wherever products are software-defined and regulated, the question is the same: what is affected, and can we prove it? Start where the pressure is highest, then scale the same governed thread across your portfolio.

Automotive: where the pressure peaks

The lead use case. UN R155 and ISO/SAE 21434 cyber evidence, ASPICE conformity, ISO 26262 and SOTIF safety, NHTSA inquiry response and OTA as recall remedy, with evidence per variant and per VIN.

The lead use case. UN R155 and ISO/SAE 21434 cyber evidence, ASPICE conformity, ISO 26262 and SOTIF safety, NHTSA inquiry response and OTA as recall remedy, with evidence per variant and per VIN. See Automotive Trends

Aerospace and defense

Digital engineering and MBSE expectations, deep requirements traceability and long-lived variants. One governed thread carries evidence from requirement to sustainment.

Digital engineering and MBSE expectations, deep requirements traceability and long-lived variants. One governed thread carries evidence from requirement to sustainment.

MedTech

Design controls and regulatory submissions need traceability from requirement to risk to test. Deloitte regulatory expertise meets the PTC spine for FDA and EU MDR evidence.

Design controls and regulatory submissions need traceability from requirement to risk to test. Deloitte regulatory expertise meets the PTC spine for FDA and EU MDR evidence.

Industrial equipment

Configurable machines and connected products bring functional safety and cybersecurity obligations. Variant-aware evidence keeps every configuration audit-ready.

Configurable machines and connected products bring functional safety and cybersecurity obligations. Variant-aware evidence keeps every configuration audit-ready.

Electronics and high-tech

Fast release cycles and software-heavy products need change impact as a query and compliance evidence that keeps pace with every release.

Fast release cycles and software-heavy products need change impact as a query and compliance evidence that keeps pace with every release.

Governance agents across the V-cycle, on the PTC product spine

Deloitte’s orchestration layer places four always-on governance agents (Quality Gate, Traceability, Risk and Configuration) across the V-cycle, plus agents attached to each phase from requirements to field validation. They read from and write to the PTC products that hold your requirements, variants, change, design and field data. Evidence is generated as engineering happens, per variant instead of per program.

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Six PTC products. One governed thread.

Each PTC product keeps its own intelligence. The agents are layered on top and connect them, so a question that crosses six systems gets one answer.

Each PTC product keeps its own intelligence. The agents are layered on top and connect them, so a question that crosses six systems gets one answer.

Codebeamer: the ALM spine

Holds requirements, tests and evidence. ASPICE and cyber/CSMS agents generate evidence directly from ALM artifacts, with requirements decomposed across hardware and software.

Holds requirements, tests and evidence. ASPICE and cyber/CSMS agents generate evidence directly from ALM artifacts, with requirements decomposed across hardware and software. Explore Codebeamer

Windchill: the PLM backbone

Holds change and the BOM. A change impact agent traces every change from PLM to ERP to supplier, and a safety issue lifecycle agent supports regulator inquiries.

Holds change and the BOM. A change impact agent traces every change from PLM to ERP to supplier, and a safety issue lifecycle agent supports regulator inquiries. Explore Windchill

Pure Variants: variant management

Manages the variant matrix. Agents resolve which configurations are affected and generate evidence per variant, so what’s built once applies across platforms.

Manages the variant matrix. Agents resolve which configurations are affected and generate evidence per variant, so what’s built once applies across platforms. Explore Pure Variants

Creo: design in the thread

Brings design into the evidence chain. A design-to-requirements agent closes the loop back into Codebeamer, with functional safety evidence threaded through.

Brings design into the evidence chain. A design-to-requirements agent closes the loop back into Codebeamer, with functional safety evidence threaded through. Explore Creo

Why Deloitte and PTC deliver compliance at scale

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Deloitte: the orchestration layer

Deloitte brings the governance agents, the methodology and the enterprise transformation. Its systems engineers, CMMI-DEV appraisers and PLM architects come from OEM and Tier-1 roles, with methodology anchored in INCOSE, ISO/IEC/IEEE 15288 and 29148, ISO 26262 and ISO/SAE 21434.

Explore the Alliance
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PTC: the governed product spine

PTC brings the governed data. Codebeamer, Windchill, Pure Variants, Creo, ServiceMax and Servigistics hold requirements, variants, change, design and field data as digital artifacts the agents can query. Agents are only as good as the data they run on. Together: one governed thread from first requirement to the product in the field.

Meet the Deloitte Partnership
Perspectives and resources from Deloitte and PTC on software-defined products, product line engineering and AI-driven compliance.
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