Solution
Your Entire Design History. On One Sheet.
Design controls expect an unbroken chain from user need to V&V — and an inspector will walk it. Nextedy makes that chain native to Polarion, editable as the device changes rather than assembled before the audit.
Solution
Your Entire Design History. On One Sheet.
Design controls expect an unbroken chain from user need to V&V — and an inspector will walk it. Nextedy makes that chain native to Polarion, editable as the device changes rather than assembled before the audit.
Solution
Your Entire Design History. On One Sheet.
Design controls expect an unbroken chain from user need to V&V — and an inspector will walk it. Nextedy makes that chain native to Polarion, editable as the device changes rather than assembled before the audit.
Problem
The Design History File Gets Rebuilt, Not Maintained
Design controls expect a live chain from user need to V&V. Most teams assemble it in Excel the month before an inspection.
By then the device has moved on. Nobody can say which links were checked
and which were assumed.
Comparison
Why Not Just Use Polarion Reports or Excel?
Capability
POWERSHEET
Polarion Reports
Excel
Live & Editable
✅
❌
✅ But Disconnected
Version-Controlled
✅
⚠️ No Compare
❌
Native Polarion Integration
✅
✅
❌
Deep Hierarchies
✅ Unlimited
✅ Manual
✅ Manual
Configurable Views
✅ No-Code
❌ Static
❌ High Maintenance
Solution
One Live Thread — From User Need to Validated Device
Any Depth. Nothing Flattened.
Trace from user need through design inputs and outputs to V&V results — the design-controls chain FDA auditors walk, at any depth.
User need → input → output → V&V, unbroken
Any number of levels — nothing gets flattened
Every hop is a live Polarion link
The Risk File Meets the DHF
Requirements chain and risk chain as connected live grids on the same work items — no export joins them, the database does.
Needs, risks (ISO 14971), and tests — connected live grids
Follow links across documents and projects
Gaps appear as empty cells — instantly visible
Feels Like Excel. Lives in Polarion.
Sort, filter, copy/paste, or edit live — POWERSHEET behaves like Excel but runs on your live Polarion work items.
Sort, filter, and bulk-edit in place
Copy and paste between sheets and Excel
Every edit lands on the live work item
Design Controls That Enforce Themselves
Create a design input from the sheet and it lands in the right specification, linked to its source — the model enforces it.
Rules decide where new artifacts go
Invalid links are rejected before save
Design controls hold by construction
Nothing Leaves Polarion
Everything stays in Polarion. No external storage, no sync jobs — one validated system, one record.
No external storage, no data syncs
Polarion permissions apply everywhere
Less to validate, nothing to reconcile
Impact Analysis in Seconds
A design input changes — see every affected output, risk, and test before the change ships, not in the audit.
Change impact across the whole DHF
Open the matrix at any revision your auditor asks about
Export the matrix your auditor asks for
Solution
One Live Thread — From User Need to Validated Device
Any Depth. Nothing Flattened.
Trace from user need through design inputs and outputs to V&V results — the design-controls chain FDA auditors walk, at any depth.
User need → input → output → V&V, unbroken
Any number of levels — nothing gets flattened
Every hop is a live Polarion link
The Risk File Meets the DHF
Requirements chain and risk chain as connected live grids on the same work items — no export joins them, the database does.
Needs, risks (ISO 14971), and tests — connected live grids
Follow links across documents and projects
Gaps appear as empty cells — instantly visible
Feels Like Excel. Lives in Polarion.
Sort, filter, copy/paste, or edit live — POWERSHEET behaves like Excel but runs on your live Polarion work items.
Sort, filter, and bulk-edit in place
Copy and paste between sheets and Excel
Every edit lands on the live work item
Design Controls That Enforce Themselves
Create a design input from the sheet and it lands in the right specification, linked to its source — the model enforces it.
Rules decide where new artifacts go
Invalid links are rejected before save
Design controls hold by construction
Nothing Leaves Polarion
Everything stays in Polarion. No external storage, no sync jobs — one validated system, one record.
No external storage, no data syncs
Polarion permissions apply everywhere
Less to validate, nothing to reconcile
Impact Analysis in Seconds
A design input changes — see every affected output, risk, and test before the change ships, not in the audit.
Change impact across the whole DHF
Open the matrix at any revision your auditor asks about
Export the matrix your auditor asks for
Solution
One Live Thread — From User Need to Validated Device
Any Depth. Nothing Flattened.
Trace from user need through design inputs and outputs to V&V results — the design-controls chain FDA auditors walk, at any depth.
User need → input → output → V&V, unbroken
Any number of levels — nothing gets flattened
Every hop is a live Polarion link
The Risk File Meets the DHF
Requirements chain and risk chain as connected live grids on the same work items — no export joins them, the database does.
Needs, risks (ISO 14971), and tests — connected live grids
Follow links across documents and projects
Gaps appear as empty cells — instantly visible
Feels Like Excel. Lives in Polarion.
Sort, filter, copy/paste, or edit live — POWERSHEET behaves like Excel but runs on your live Polarion work items.
Sort, filter, and bulk-edit in place
Copy and paste between sheets and Excel
Every edit lands on the live work item
Design Controls That Enforce Themselves
Create a design input from the sheet and it lands in the right specification, linked to its source — the model enforces it.
Rules decide where new artifacts go
Invalid links are rejected before save
Design controls hold by construction
Nothing Leaves Polarion
Everything stays in Polarion. No external storage, no sync jobs — one validated system, one record.
No external storage, no data syncs
Polarion permissions apply everywhere
Less to validate, nothing to reconcile
Impact Analysis in Seconds
A design input changes — see every affected output, risk, and test before the change ships, not in the audit.
Change impact across the whole DHF
Open the matrix at any revision your auditor asks about
Export the matrix your auditor asks for
AI Assistant Capabilities
AI That Knows a Design Input From an Output. Engineers Who Stay in Control.
POWERSHEET AI Assistant knows the design-controls ontology — user needs, design inputs, outputs, V&V results, and the links that connect them. It proposes; you accept, edit, or reject — and every decision is stored in Polarion. AI does not sign off.
Identify a Gap
Missing links, uncovered requirements, or orphaned tests — surfaced directly in the matrix.
Review Evidence
Every suggestion arrives with its reasoning and sources — project history and your design-controls context.
Commit to Grid
One click applies human-approved links into the matrix — a live link, immediately audit-ready.
AI Assistant Capabilities
AI That Knows a Design Input From an Output. Engineers Who Stay in Control.
POWERSHEET AI Assistant knows the design-controls ontology — user needs, design inputs, outputs, V&V results, and the links that connect them. It proposes; you accept, edit, or reject — and every decision is stored in Polarion. AI does not sign off.
Identify a Gap
Missing links, uncovered requirements, or orphaned tests — surfaced directly in the matrix.
Review Evidence
Every suggestion arrives with its reasoning and sources — project history and your design-controls context.
Commit to Grid
One click applies human-approved links into the matrix — a live link, immediately audit-ready.
AI Assistant Capabilities
AI That Knows a Design Input From an Output. Engineers Who Stay in Control.
POWERSHEET AI Assistant knows the design-controls ontology — user needs, design inputs, outputs, V&V results, and the links that connect them. It proposes; you accept, edit, or reject — and every decision is stored in Polarion. AI does not sign off.
Identify a Gap
Missing links, uncovered requirements, or orphaned tests — surfaced directly in the matrix.
Review Evidence
Every suggestion arrives with its reasoning and sources — project history and your design-controls context.
Commit to Grid
One click applies human-approved links into the matrix — 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
“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.
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.
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.
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.
Functional Safety and Cybersecurity Belong Together
Functional Safety and Cybersecurity Belong Together
Discover Nextedy’s functional safety and cybersecurity solutions for regulated industries — built on the same RISKSHEET foundation.
Discover Nextedy’s functional safety and cybersecurity solutions for regulated industries — built on the same RISKSHEET foundation.
