Change Impact Intelligence
EIS sits between your development tools and your compliance evidence — so when something changes anywhere, you know exactly what's at risk across every layer.
Layer
Meet e-Pilot
Ask questions in plain language. Get instant answers across every layer.
Traced the change. Here's what needs re-verification:
Natural Language Queries
Ask "what breaks if I change this tolerance?" in plain English. e-Pilot traces across requirements, drawings, schematics, and test records instantly.
Cross-Layer Integration
EIS connects GitHub, Jira, your hardware drawings, electronics, and test management — so changes in any tool propagate through the full V&V chain.
Private & Tenant-Isolated
Your standards, protocols, and engineering decisions are indexed in a private vector store. Your IP never leaves your tenant, never trains a model.
Continuous Compliance Evidence
Every test run, approval, and change is automatically added to your assurance record. Audits become a read-out, not a scramble.
Know exactly what went into every device. Recall-ready in minutes.
EIS links every component lot through production to the device serial number that left your facility. Incoming inspection records, test results, and supplier certificates — all attached to the same immutable chain. When a supplier flags a defect, your recall scope is confirmed in seconds, not days.
Supplier flags a defective lot. EIS traces every device it touched, where they shipped, and which tests they passed — before you pick up the phone to regulators.
Know exactly which DMR revision each unit was built to. No more 'which BOM is right?' — the chain of custody from design to device is unbroken and auditable.
Incoming lot certificates and IQ test results attach to component records at intake — so supplier qualification evidence is always one click away, not buried in email.
§820.65 and ISO 13485 §7.5.9 require it. EIS makes it automatic — every production record, test result, and material identification links to the device history record in real time.
No more 3-month panic before your audit
EIS compiles your compliance evidence continuously — every NC, CAPA action, effectiveness check, and closure is automatically linked into the audit package. When a notified body or FDA inspector arrives, the record is already complete.
Engineers drive. EIS records. Every pass/fail verdict, operator override, and approval decision is captured with a tamper-evident signature hash — so your audit trail is as strong as your engineering record.
NC raised, root cause identified, action taken, effectiveness verified, CAPA closed — every step linked to the evidence that proves it. No spreadsheet, no paper trail.
When a design change triggers re-validation, EIS traces the blast radius — which tests are truly affected. Stop blanket re-validation. Cut re-qualification cycles by 60%.
SOPs, test records, CAPA closures, drawing revisions — continuously added to your DHF/QMS as work happens. No pre-audit sprint. Just open EIS and print.
Field returns, complaints, and vigilance reports link to the device history record — so corrective actions trace back to the exact design version and production lot.
What your team deals with today. What EIS does instead.
CAD tolerance updated. Traceability matrix still shows "verified" against the old value.
Every affected requirement, test, and risk control flagged the moment the change lands. No manual triage.
3 weeks reconciling SharePoint, Jira, and Excel before each NB assessment.
Evidence assembled continuously. Walk into any audit with a live, clause-by-clause record — already complete.
Orphan requirements added mid-project are invisible in a spreadsheet until the auditor finds them.
Every design input linked to outputs in real time. Gaps surface immediately, not at submission.
Supplier flags a defective lot. Identifying which units are at risk takes days of spreadsheet archaeology.
Incoming inspection, DHR, and supplier certs linked to the design record. Recall scope confirmed in seconds.
Failed test → root cause → CAPA, all in separate tools, manually linked by whoever has time.
Failed test triggers AI root cause. CAPA record created and closed automatically with a full evidence trail.
Post-market complaints manually triaged against the risk file. Substantial change decisions made by gut.
Complaints classified against ISO 14971 risk controls the moment they arrive. Threshold crossed? You know first.
Technical File assembled the night before the audit from scattered folders across three systems.
Annex I GSPR verdicts from live evidence. The Technical File is always current — not assembled, maintained.
Senior engineer leaves. The reasoning behind design decisions disappears with them.
Every decision, rationale, and change captured at the moment it happens. Context survives team changes.