Solution

Functional Safety for Industrial Systems. Inside Polarion. Evidence-Ready by Design.

A safety case is only as current as the day it was assembled. Nextedy brings hazard analysis and SIL determination into Polarion — connected to verification through commissioning and every modification that follows, not rebuilt before each assessment.

Solution

Functional Safety for Industrial Systems. Inside Polarion. Evidence-Ready by Design.

A safety case is only as current as the day it was assembled. Nextedy brings hazard analysis and SIL determination into Polarion — connected to verification through commissioning and every modification that follows, not rebuilt before each assessment.

Solution

Functional Safety for Industrial Systems. Inside Polarion. Evidence-Ready by Design.

A safety case is only as current as the day it was assembled. Nextedy brings hazard analysis and SIL determination into Polarion — connected to verification through commissioning and every modification that follows, not rebuilt before each assessment.

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Problem

The Core Question: How Many of Your System Requirements are Really Born from Risk?

General Safety-Critical Systems
30–60 %
High-Integrity Systems
60–80 %
Regulated IT/Automation Systems
40–70 %
Cybersecurity Requirements
80–100 %

In industrial systems, safety requirements are born the same way: hazards drive safety functions, safety functions carry a SIL, and every derived requirement must trace back to one — and forward to its verification.

The Work Exists. The Evidence Chain Is Fragile.

60–80% of requirements come from risk analyses, yet most organizations run them in separate spreadsheets, disconnected from requirements.

Risk, requirements and verification drift apart; traceability becomes manual; the functional safety assessment turns into a fire drill.

Solution

One Engineering Record. From Safety Function to Evidence.

Requirements, Risks, and Verification — One System.

Safety functions create requirements. Requirements need verification. When hazard analysis and FMEA live in the same system as both, the chain — hazard → safety function (SIL) → requirement → test → residual risk — is already linked, in one view. Traceability becomes a by-product of engineering: it’s a column the analyst already sees.

Eliminate exports and silos

Improve collaboration across safety, engineering, and V&V

Connect hazard analysis and FMEA directly to downstream work

Feels Like Excel. Behaves Like a Database.

Analysts think in rows. Assessors think in records. You shouldn’t have to choose. RISKSHEET gives your team the spreadsheet ergonomics they know — while every row is a live Polarion Work Item: traced, versioned, permission-controlled. Risk levels and SIL determination recalculate as you type; threshold colors surface the highest risks at a glance.

Reduce the learning curve

Manage large hazard analyses and detailed FMEAs efficiently

Get instant feedback from live calculations and evaluations

Every Analysis. One Record. Your Interpretation.

The tool doesn’t prescribe your process — the template does. Run hazard analysis and PHA, FMEA and FMEDA, HAZOP, and SIL verification as connected sheets over the same live Polarion data. IEC 61508 sits underneath; its sector standards sit on top — IEC 62061 and ISO 13849 for machinery, EN 5012x for rail, IEC 61511 for process, IEC 61513 for nuclear. Configure fields, scales, SIL logic and workflows to how your organization reads the standard.

Start from best-practice templates

Adapt fields, logic, and workflows to your process

Drive consistency across teams and programs

A Risk Isn’t Closed When It’s Rated.

It’s closed when its safety function, requirement, verification, and residual risk are connected. In RISKSHEET, a safety measure becomes a live Polarion work item with an owner, a workflow state, and a due date — its status mirrored back into the sheet. Reviews and approvals run on your existing Polarion workflows; every change writes itself into the audit trail.

Configure review and approval flows

Trigger notifications automatically

Maintain a clear audit trail for every change

Not “Analysis Once.” Evidence That Survives Change.

Safety evidence is a lifecycle obligation: it must stay maintained as the product changes — through design iterations, variants, field returns, and in-service findings. Baseline at every milestone, compare revisions, and see exactly which hazards, requirements, and verifications a change touches.

Baseline assessments at key milestones

Compare revisions and identify deltas instantly

Support change impact analysis with confidence

The Safety Case — Generated, Not Assembled.

Your safety case should be read from maintained engineering data — not reconstructed before the assessment. Generate work products, hazard analyses, FMEA workbooks, traceability matrices, and audit trails on demand, from the same live record your engineers work in.

Export hazard analyses, FMEA, matrices and audit trails

Keep reports accurate and up to date

Generate documentation from a single source of truth

Solution

One Engineering Record. From Safety Function to Evidence.

Requirements, Risks, and Verification — One System.

Safety functions create requirements. Requirements need verification. When hazard analysis and FMEA live in the same system as both, the chain — hazard → safety function (SIL) → requirement → test → residual risk — is already linked, in one view. Traceability becomes a by-product of engineering: it’s a column the analyst already sees.

Eliminate exports and silos

Improve collaboration across safety, engineering, and V&V

Connect hazard analysis and FMEA directly to downstream work

Feels Like Excel. Behaves Like a Database.

Analysts think in rows. Assessors think in records. You shouldn’t have to choose. RISKSHEET gives your team the spreadsheet ergonomics they know — while every row is a live Polarion Work Item: traced, versioned, permission-controlled. Risk levels and SIL determination recalculate as you type; threshold colors surface the highest risks at a glance.

Reduce the learning curve

Manage large hazard analyses and detailed FMEAs efficiently

Get instant feedback from live calculations and evaluations

Every Analysis. One Record. Your Interpretation.

The tool doesn’t prescribe your process — the template does. Run hazard analysis and PHA, FMEA and FMEDA, HAZOP, and SIL verification as connected sheets over the same live Polarion data. IEC 61508 sits underneath; its sector standards sit on top — IEC 62061 and ISO 13849 for machinery, EN 5012x for rail, IEC 61511 for process, IEC 61513 for nuclear. Configure fields, scales, SIL logic and workflows to how your organization reads the standard.

Start from best-practice templates

Adapt fields, logic, and workflows to your process

Drive consistency across teams and programs

A Risk Isn’t Closed When It’s Rated.

It’s closed when its safety function, requirement, verification, and residual risk are connected. In RISKSHEET, a safety measure becomes a live Polarion work item with an owner, a workflow state, and a due date — its status mirrored back into the sheet. Reviews and approvals run on your existing Polarion workflows; every change writes itself into the audit trail.

Configure review and approval flows

Trigger notifications automatically

Maintain a clear audit trail for every change

Not “Analysis Once.” Evidence That Survives Change.

Safety evidence is a lifecycle obligation: it must stay maintained as the product changes — through design iterations, variants, field returns, and in-service findings. Baseline at every milestone, compare revisions, and see exactly which hazards, requirements, and verifications a change touches.

Baseline assessments at key milestones

Compare revisions and identify deltas instantly

Support change impact analysis with confidence

The Safety Case — Generated, Not Assembled.

Your safety case should be read from maintained engineering data — not reconstructed before the assessment. Generate work products, hazard analyses, FMEA workbooks, traceability matrices, and audit trails on demand, from the same live record your engineers work in.

Export hazard analyses, FMEA, matrices and audit trails

Keep reports accurate and up to date

Generate documentation from a single source of truth

Solution

One Engineering Record. From Safety Function to Evidence.

Requirements, Risks, and Verification — One System.

Safety functions create requirements. Requirements need verification. When hazard analysis and FMEA live in the same system as both, the chain — hazard → safety function (SIL) → requirement → test → residual risk — is already linked, in one view. Traceability becomes a by-product of engineering: it’s a column the analyst already sees.

Eliminate exports and silos

Improve collaboration across safety, engineering, and V&V

Connect hazard analysis and FMEA directly to downstream work

Feels Like Excel. Behaves Like a Database.

Analysts think in rows. Assessors think in records. You shouldn’t have to choose. RISKSHEET gives your team the spreadsheet ergonomics they know — while every row is a live Polarion Work Item: traced, versioned, permission-controlled. Risk levels and SIL determination recalculate as you type; threshold colors surface the highest risks at a glance.

Reduce the learning curve

Manage large hazard analyses and detailed FMEAs efficiently

Get instant feedback from live calculations and evaluations

Every Analysis. One Record. Your Interpretation.

The tool doesn’t prescribe your process — the template does. Run hazard analysis and PHA, FMEA and FMEDA, HAZOP, and SIL verification as connected sheets over the same live Polarion data. IEC 61508 sits underneath; its sector standards sit on top — IEC 62061 and ISO 13849 for machinery, EN 5012x for rail, IEC 61511 for process, IEC 61513 for nuclear. Configure fields, scales, SIL logic and workflows to how your organization reads the standard.

Start from best-practice templates

Adapt fields, logic, and workflows to your process

Drive consistency across teams and programs

A Risk Isn’t Closed When It’s Rated.

It’s closed when its safety function, requirement, verification, and residual risk are connected. In RISKSHEET, a safety measure becomes a live Polarion work item with an owner, a workflow state, and a due date — its status mirrored back into the sheet. Reviews and approvals run on your existing Polarion workflows; every change writes itself into the audit trail.

Configure review and approval flows

Trigger notifications automatically

Maintain a clear audit trail for every change

Not “Analysis Once.” Evidence That Survives Change.

Safety evidence is a lifecycle obligation: it must stay maintained as the product changes — through design iterations, variants, field returns, and in-service findings. Baseline at every milestone, compare revisions, and see exactly which hazards, requirements, and verifications a change touches.

Baseline assessments at key milestones

Compare revisions and identify deltas instantly

Support change impact analysis with confidence

The Safety Case — Generated, Not Assembled.

Your safety case should be read from maintained engineering data — not reconstructed before the assessment. Generate work products, hazard analyses, FMEA workbooks, traceability matrices, and audit trails on demand, from the same live record your engineers work in.

Export hazard analyses, FMEA, matrices and audit trails

Keep reports accurate and up to date

Generate documentation from a single source of truth

AI Assistant Capabilities

AI That Knows a Safety Function From a Safety Requirement. Engineers Who Stay in Control.

RISKSHEET AI Assistant knows your safety ontology — hazards, safety functions, SILs, safety requirements, and the verification that closes them. It proposes; you accept, edit, or reject — and every decision is stored in Polarion. AI does not sign off.

Identify a Gap

Missing hazards, safety functions without a SIL, or inconsistent risk ratings — surfaced in the sheet.

Review Evidence

Every suggestion arrives with its reasoning and sources — project history and the safety standards.

Commit to Grid

One click applies human-approved content into the safety record — a live link, immediately audit-ready.

AI Assistant Capabilities

AI That Knows a Safety Function From a Safety Requirement. Engineers Who Stay in Control.

RISKSHEET AI Assistant knows your safety ontology — hazards, safety functions, SILs, safety requirements, and the verification that closes them. It proposes; you accept, edit, or reject — and every decision is stored in Polarion. AI does not sign off.

Identify a Gap

Missing hazards, safety functions without a SIL, or inconsistent risk ratings — surfaced in the sheet.

Review Evidence

Every suggestion arrives with its reasoning and sources — project history and the safety standards.

Commit to Grid

One click applies human-approved content into the safety record — a live link, immediately audit-ready.

AI Assistant Capabilities

AI That Knows a Safety Function From a Safety Requirement. Engineers Who Stay in Control.

RISKSHEET AI Assistant knows your safety ontology — hazards, safety functions, SILs, safety requirements, and the verification that closes them. It proposes; you accept, edit, or reject — and every decision is stored in Polarion. AI does not sign off.

Identify a Gap

Missing hazards, safety functions without a SIL, or inconsistent risk ratings — surfaced in the sheet.

Review Evidence

Every suggestion arrives with its reasoning and sources — project history and the safety standards.

Commit to Grid

One click applies human-approved content into the safety record — a live link, immediately audit-ready.

Why Nextedy

Our Expertise, Your Advantage

We build native applications that extend Polarion ALM into the workflows it doesn’t cover — purpose-built for automotive, medical device, and aerospace teams. A certified Siemens Solution Partner trusted by 130,000+ licensed users, Nextedy doubles the value of your Polarion investment.

Why Nextedy

Our Expertise, Your Advantage

We build native applications that extend Polarion ALM into the workflows it doesn’t cover — purpose-built for automotive, medical device, and aerospace teams. A certified Siemens Solution Partner trusted by 130,000+ licensed users, Nextedy doubles the value of your Polarion investment.

Why Nextedy

Our Expertise, Your Advantage

We build native applications that extend Polarion ALM into the workflows it doesn’t cover — purpose-built for automotive, medical device, and aerospace teams. A certified Siemens Solution Partner trusted by 130,000+ licensed users, Nextedy doubles the value of your Polarion investment.

Trusted by Industry Leaders
Trusted by Industry Leaders
Trusted by Industry Leaders

Our Customers

Industry Leaders Rely on Nextedy

“At J&J we have been using Nextedy’s software to enhance our Polarion experience, and we couldn’t be more impressed. Their products have proven to be invaluable in improving the functionality and efficiency of our operations.”

Senior Manager

Advanced R&D-Digital Tooling

at Johnson&Johnson MedTech

“At J&J we have been using Nextedy’s software to enhance our Polarion experience, and we couldn’t be more impressed. Their products have proven to be invaluable in improving the functionality and efficiency of our operations.”

Senior Manager

Advanced R&D-Digital Tooling

at Johnson&Johnson MedTech

“At J&J we have been using Nextedy’s software to enhance our Polarion experience, and we couldn’t be more impressed. Their products have proven to be invaluable in improving the functionality and efficiency of our operations.”

Senior Manager

Advanced R&D-Digital Tooling

at Johnson&Johnson MedTech

How Optum Tech Streamlined Test-Case Inventory Management with Nextedy RISKSHEET

How Optum Tech Streamlined Test-Case Inventory Management with Nextedy RISKSHEET

How Optum Tech Streamlined Test-Case Inventory Management with Nextedy RISKSHEET

“At Schaeffler, we have found the Nextedy Apps to be well-integrated with Polarion, offering a seamless and highly cohesive user experience. The products and their tight integration enable efficient and accurate planning within the system and software domains.”

Schaeffler

Armin Graf

“Nextedy GANTT works very smoothly, and working with Nextedy and their support team is always a pleasure.”

Viessmann

Bastian Strauss

“The Nextedy CHECKLIST and GANTT play a vital role in this success — by providing clear structures, reliable planning, and seamless integration into the Polarion engineering environment.”

Arnold NextG

Automotive Supplier

Layers

Native-by-Design Architecture

Unlike competitors relying on integrations, Nextedy delivers a native experience directly on top of the underlying data platform, ensuring a single source of truth.

Familiar Interface. Days to Adopt. Real-Time Data.

Work inside a familiar graphical interface — inline editing, real-time filtering, color-coded formatting — without ever leaving Polarion. Your team adopts it in days, not months.

One Database for all Data. Zero Sync.

Full traceability, audit readiness, and boundary-free reporting.

Security and Privacy by Design.

Built on the platform layer, so your existing Polarion permissions and audit trail apply unchanged.

Your Workflows. Your Data Model.

Works with your existing configuration. Nothing to re-model, nothing to duplicate.

Layers

Native-by-Design Architecture

Unlike competitors relying on integrations, Nextedy delivers a native experience directly on top of the underlying data platform, ensuring a single source of truth.

Familiar Interface. Days to Adopt. Real-Time Data.

Work inside a familiar graphical interface — inline editing, real-time filtering, color-coded formatting — without ever leaving Polarion. Your team adopts it in days, not months.

One Database for all Data. Zero Sync.

Full traceability, audit readiness, and boundary-free reporting.

Security and Privacy by Design.

Built on the platform layer, so your existing Polarion permissions and audit trail apply unchanged.

Structured reviews with accountability.

Configurable checklists linked to work items. Gate your process with reviews that leave an auditable trail.

Layers

Native-by-Design Architecture

Unlike competitors relying on integrations, Nextedy delivers a native experience directly on top of the underlying data platform, ensuring a single source of truth.

Familiar Interface. Days to Adopt. Real-Time Data.

Work inside a familiar graphical interface — inline editing, real-time filtering, color-coded formatting — without ever leaving Polarion. Your team adopts it in days, not months.

One Database for all Data. Zero Sync.

Full traceability, audit readiness, and boundary-free reporting.

Security and Privacy by Design.

Built on the platform layer, so your existing Polarion permissions and audit trail apply unchanged.

Your Workflows. Your Data Model.

Works with your existing configuration. Nothing to re-model, nothing to duplicate.

Pricing

Get a Quote Tailored to Your Team

How Are Products Licensed?

As an annual software subscription. Active users of a given app need a Named Active User license for that product; a Connect license is required per server and gives every Polarion user read-only access to that app's views as a report. A commercial license covers one production instance on one Polarion server, including a load-balanced or multi-node cluster.

Pricing

Get a Quote Tailored to Your Team

How Are Products Licensed?

As an annual software subscription. Active users of a given app need a Named Active User license for that product; a Connect license is required per server and gives every Polarion user read-only access to that app's views as a report. A commercial license covers one production instance on one Polarion server, including a load-balanced or multi-node cluster.

Pricing

Get a Quote Tailored to Your Team

How Are Products Licensed?

As an annual software subscription. Active users of a given app need a Named Active User license for that product; a Connect license is required per server and gives every Polarion user read-only access to that app's views as a report. A commercial license covers one production instance on one Polarion server, including a load-balanced or multi-node cluster.

When a Security Threat Can Defeat a Safety Function, One Record Must Show Both.

When a Security Threat Can Defeat a Safety Function, One Record Must Show Both.

Safety sees the hazard. Security sees the threat. Increasingly, one control serves both — and IEC 62443 brings industrial cybersecurity into the same lifecycle discipline as IEC 61508 safety. Nextedy runs both on the same Polarion record, with a bridge between them — a security risk with a safety effect links straight into your assessment.

Safety sees the hazard. Security sees the threat. Increasingly, one control serves both — and IEC 62443 brings industrial cybersecurity into the same lifecycle discipline as IEC 61508 safety. Nextedy runs both on the same Polarion record, with a bridge between them — a security risk with a safety effect links straight into your assessment.