Streamline quality & compliance with a modern, GxP-aligned QMS
Manage SOPs, controlled documents, audits, approvals, CAPA, and training in one secure platform — with electronic signatures, role-based access, and a complete audit trail on every record.
Everything quality teams need, in one connected system
Document control, SOPs, workflows, audits, CAPA, and training share a single record — so nothing falls between tools and every action is captured.
Document management
Centralized, controlled document storage with a folder hierarchy, drag-and-drop upload, and structured organization across the whole organization.
SOP management
Author, route, and publish standard operating procedures with effective dates, periodic-review scheduling, and automatic retirement of old versions.
Version control
Full revision history with change reason, field-level diffs, and a clear current-vs-superseded state — so only the right version is ever in use.
Approval workflows
Reviewer, approver, auditor, and employee roles with automated routing — each step bound to an electronic signature and notification.
Audit management
Plan, schedule, and track internal and supplier audits — log findings, link them to CAPA, and keep a defensible record for inspection readiness.
Training & compliance
Assign training on document release, capture read-and-understood acknowledgements, and monitor completion on a live compliance dashboard.
From draft to controlled — one governed lifecycle
Every document and SOP follows the same eight-stage path, with the right people accountable at each step and the loop closing back to revision control.
Create document / SOP
Author starts from a controlled template; metadata, owner, and document type are set on creation.
Assign reviewer
Routing sends the draft to the responsible reviewer with a due date and automated reminder.
Review & comments
Reviewer annotates inline, requests changes, and the author resolves comments in-thread.
Approver validation
Approver signs off with a 21 CFR Part 11 electronic signature capturing meaning and identity.
Publish document
On final approval the document becomes effective and is released to the right audience.
Employee access
Staff see only the current effective version, with training assigned automatically on release.
Audit & compliance tracking
Every action is logged; reviews, training, and findings roll up to the compliance dashboard.
Revision & version control
Change requests open a new draft; the prior version is retired and retained for the record.
The loop closes. Revision control feeds straight back into step 1 — a new draft inherits history, ownership, and training links, so the lifecycle stays continuous and fully traceable.
Approvals route themselves
Define the path once and every document follows it — sequential or parallel, with automatic escalation, reminders, and electronic signatures captured at each gate.
Conditional rules send each document to the right reviewer and approver in the right order.
Due-date reminders and escalation keep tasks moving and reviews from going overdue.
Each gate captures signer identity, meaning, and timestamp — bound to the record under Part 11.
Always inspection-ready
A complete, tamper-evident audit trail records who did what and when — with before/after values, electronic signatures, and CAPA tied to findings. Nothing to reconstruct before an audit.
Every create, read, update, and delete is captured with the acting user and a UTC timestamp.
Open corrective and preventive actions straight from audit findings and track them to closure.
Live monitoring of overdue reviews, training gaps, and open actions across the organization.
Edit where your documents already live
Open and edit controlled documents online without breaking version control. Word, Excel, and PDF stay first-class — no exporting, no re-uploading, no lost revisions.
Co-author in the browser; changes are versioned automatically against the controlled record.
Full-text search across metadata and content finds the exact document and version in seconds.
Least-privilege, enforced by role
Role-based access control grants only the permissions each function needs. Reviewers, approvers, auditors, and employees each see exactly the right surface — and every grant is logged.
Permissions map to job function, configurable per team, and auditable on every change.
Encryption in transit and at rest, with controlled access to every controlled document.
Outcomes you can measure
A single source of truth for quality replaces scattered files, email approvals, and manual audit prep.
Controlled documents and enforced workflows keep you aligned with ISO and GxP expectations.
Every team follows the same lifecycle, templates, and approval rules — no exceptions.
Automated routing and reminders cut approval cycle time without skipping a single sign-off.
Every change, signature, and access is linked to a record you can defend in an inspection.
Generate inspector-ready exports on demand — no scramble before an audit.
One searchable home for SOPs, policies, and records — accessible to the right people.
Encrypted, access-controlled storage with full versioning and retention built in.
Less admin, fewer handoffs, and no duplicated effort across the quality function.
Bring your whole quality system into one platform
Documents, SOPs, workflows, audits, CAPA, and training — controlled, traceable, and audit-ready from day one.