Ultralight eQMS

Poor document management leads to mistakes and audit findings. Ultralight makes reviews, approvals, and version control simple.

• Track every change, automatically: From version history to approvals to downstream training, every action is logged and linked without gaps or manual effort.

• Keep teams aligned in real time: Ensure everyone is working with the latest version with a single document flow for updates, reviews, approvals, and training.

• Save time with smart workflows: Edit documents inline, schedule periodic reviews, and keep approvals moving with built-in reminders that eliminate follow-up.

Change is constant, but critical updates get lost in emails and spreadsheets. Ultralight makes updates visible, reviewable, and fully traceable from the moment they happen.

• Close the loop automatically: Every change is evaluated for risk, training, and downstream impact with built-in prompts that prevent missed steps.

• Catch issues before they spread: Connected records show what’s affected and what needs attention, from SOPs to specs to training requirements.

• Save time with guided routing: Route updates through the right reviewers, compare old and new versions side by side, and track every approval in one place.

Training records are a common audit gap that puts your compliance at risk. Our integrated training management solution lets you easily assign and track training to ensure your team is up-to-date.

• Assign the right training, automatically: Tie training to document updates with built-in policies for roles, teams, or events like new hires.

• See exactly where things stand: Track completions by person, team, or document so you always know who’s trained, what’s overdue, and what still needs to happen.

• Save hours with background compliance: No more spreadsheets, Slack reminders, or follow-ups. Ultralight routes assignments, logs completions, and handles validation behind the scenes.

Managing an approved supplier list gets messy fast. Ultralight applies the right oversight automatically, so your supply chain stays clean and compliant without the spreadsheet sprawl.

• Enforce controls by risk level: Set supplier types and risk once. The system auto-applies required docs, approvals, and monitoring.

• Keep every supplier compliant: New entries follow your defined process automatically, no extra QA policing required.

• Save time with built-in oversight: Export reports, automate reminders, and skip the manual tracking during audits.

Capturing requirements is just the start. Ultralight links your design inputs, risks, and tests from day one, so traceability builds automatically, not after the fact.

• Link as you work: Add requirements, connect risks, and flag verifications without leaving the workspace or interrupting your team’s flow.

• Flag traceability gaps before they become blockers: AI checks your requirements for verifiability, while real-time trace graphs expose missing links across design, risk, and test.

• Build your DHF in real time: Every element is versioned, reviewable, and export-ready, so you’re always ready for submission, without scrambling.

Managing quality events across multiple tools doesn’t scale and creates compliance gaps. Ultralight helps you manage all events in one place, so you can close them out faster and stay audit-ready.

• Configure workflows to fit your process: Start from best-practice templates or fully tailor event types, stages, questions, and required fields as your team evolves.

• Link issues to what matters: Every event ties directly to affected products, documents, and changes, giving you a complete quality record without digging.

• Route and sign off without delays: Assign tasks, route reviews in parallel or sequence, and sign digitally with 21 CFR Part 11-compliant approvals built into the flow.

Managing the software release lifecycle is complicated, especially when you need to connect code changes and test reports with your quality processes. Ultralight gives you a single, unified view to orchestrate every release, no matter how complex.

• Release with confidence: Intentionally built to align with IEC 62304, Ultralight lets you configure release forms, reference affected software parts, and tie all code changes and pull requests to a single release.

• Keep engineers in their dev tools: Automatically sync tests and documentation from tools like GitHub, so engineers can continue working with the systems they love.

• Generate an audit-ready Design History File: Automatically pull test results and other documentation directly into your DHF for a complete, up-to-date record that's ready for any audit.

Managing controlled components, drawings, and revisions can get complicated quickly. Ultralight provides a dedicated workspace for tracking every part, ensuring you have a complete, connected view of your product from end to end.

• Centralize your parts: Define part types and use automated, custom IDs to create a single source of truth for all your parts, complete with metadata and links to CAD files, specs, and related documents.

• Control every change: Automatically manage part revisions through a built-in change control workflow, with full version tracking and approval history so you can see exactly who changed what and when.

• Build your BOM: Organize parts into hierarchies to reflect your Bill of Materials (BOM) and instantly see where a part is used across all products.