SolidPro · HelixaInspection OS · Quality Operating System
LENS
QUALITY DATA PROCESSED LOCALLY
Session start
INSPECTION OS · Medical Device Quality Operating System · RS-5.1

What would you like to do today?

One platform for running your quality system and proving it's inspection-ready. Pick where you want to start — you can move between them any time.

◈ Regulatory Knowledge Base — all 23 systems, QMSR-aligned ⇄ See how the modules connect
INSPECTION OS · Medical Device Quality Operating System · RS-5.1

Your quality system,
seen the way an inspector sees it.

Pick a regime, then inspect one system — or run the full facility in a single pass, the way a real inspection actually unfolds. Deterministic rules, your own data, nothing uploaded.

◈ View the Regulatory Knowledge Base — every rule, every citation
FDA Inspection

Choose your scope

The facility inspection runs every system you give it in one pass and tallies the combined observation count — the number that matters. Or inspect a single system first.

The full experience
Full QMS / Facility Inspection →
Inspect any combination of the 23 quality, design, manufacturing and governance systems in one pass. Load only the systems relevant to this facility and regulatory scope — with cross-system linkage checks, a combined observation tally, the executive verdict, an illustrative cost & time to fix, and a week-by-week remediation plan.
UP TO 23 SYSTEMS · ONE VERDICT

CAPA Log

Choose your data source

Full Facility Inspection

Drop what you have — the inspection runs on every log you provide (minimum one). The more systems, the truer the verdict. Cross-system linkage is checked automatically.

Want the full demo instantly?
Inspection initialising

Reading the records…

Inspection in progress

Inspection in progress

Validation Planner

No upload. Enter the parameters; the bench computes the ASTM/ISO matrix, the real F1980 accelerated-aging duration, and hands you a protocol skeleton you can download.

Operational workspace

Workspace

Create and maintain records here — this is your live QMS. Every record carries an owner, a status, a workflow stage and an edit history (for demonstration). When you're ready, one button runs the inspection on exactly these records.

COMMAND CENTER · your quality system, live

Quality Command Center

The executive view — built from every inspection you've run in this browser. Readiness, risk, trends, and what an investigator would find next.

Admin Console

Access control, people, captured leads & integration — everything runs in this browser. Preview-all lets you explore every feature unlocked.
Demonstration access only. This PIN (default 2468) is a local, browser-stored gate — it is not authentication.
Compliance scope — what this edition does and does not provide
Authentication & electronic signatures: not production-grade. No SSO, MFA, enforced RBAC, site-level permissions, segregation of duties, re-authentication at approval, signature meaning/manifestation, failed-login handling, user deactivation or session timeout. This product must not be described as 21 CFR Part 11 compliant until those controls are implemented and assessed.
Attachments: filenames are logged for demonstration; files are not stored. Production needs encrypted storage, checksums, versioning, malware scanning, preview, upload identity and timestamp, immutable history, retention and controlled deletion.
Connectors: configuration only. A saved connector is not a tested, active integration. Production needs authentication, connection testing, schema discovery, mapping approval, initial and incremental sync, an error queue, retry, reconciliation and a sync audit trail.
Data handling: quality-record contents are processed locally in this browser and are not transmitted. Web fonts and the spreadsheet library are loaded from public CDNs; self-hosting and a Content-Security-Policy are required before deployment.
Scores: readiness and observation-risk figures are illustrative indicators derived from the rule engine, not validated statistical probabilities.
SOLIDPRO ENGINEERING SERVICES · HELIXA MEDTECH · CONNECT@SOLIDPRO-ES.COM · 044-6900 4500
RULES PER 21 CFR PART 820 (QMSR) + ISO 13485 · EU MDR 2017/745 · CDSCO MDR 2017 · RULESET RS-5.1 · 23 SYSTEMS · CROSS-SYSTEM INTELLIGENCE · COMMAND CENTER. QUALITY DATA PROCESSED LOCALLY.