Audit-ready by default.
Qability is the modern Quality Management System for regulated industries. Documents, training, CAPAs, and audit trails — one system, one trail, in real time.
Built for teams under FDA · ISO · EU MDR
The product
Nine primitives. One quality system.
Documents, workflows, audit, training, CAPA, risk & RCA, inspections, suppliers, and real-time sync. The whole quality loop, in a single coherent model.
Every version. Every signature. Every decision.
Draft to effective, captured automatically. Versions, change-controls, periodic reviews — without the paperwork.
Approvals that route themselves.
Define the steps once. Qability routes, escalates, and remembers — including send-backs without losing context.
Know who changed what. Without asking.
An immutable trail of every change in the system. Pull a year of evidence in seconds. Walk into your audit with it ready.
The moment a document is effective, training is on the right desks.
Role-based assignment, automatic re-training on revision, manager verification, signature on completion.
Close the loop. Prove the fix.
Nonconformance, CAPA, and change requests — one workflow each, end to end. Auto-numbered, auto-routed, signed at completion.
From symptom to root cause — on the record.
ISO 14971 risk assessments and structured root-cause analysis — 5 Whys and Fishbone — feeding straight into the CAPA that closes them out.
Floor-captured evidence. Audit-grade.
Log books, gemba walks, and AQL acceptance sampling (ISO 2859-1 / Z1.4). Edit windows lock records into immutable, signed evidence.
Your supply base, inside the system.
Supplier register, evaluations, and document sharing — with a scoped supplier portal so partners submit and respond without ever touching the main app.
No reloads. No refreshes.
When a colleague approves, you see it. When a document goes effective, your team’s inbox already knows.
Workflows
Approvals that route themselves.
Define the steps once. Qability handles routing, escalation, send-backs, and signatures — without losing context.
Stage
Draft
Author writes against a template
Trail
Compliance
Designed around the standards — not retrofitted to them.
Audit-trail, electronic signature, change control, and training are first-class primitives. Not modules you turn on later.
E-signatures, audit trails, system controls.
General quality management foundation.
Medical device quality management.
Risk management for medical devices.
Medical Device Regulation alignment.
Quality System Regulation for medical devices.
Aerospace quality management.
Automotive quality management.
Food Safety Modernization Act.
The lifecycle
From keystroke to compliant.
Six stages, one record. The same document carries its history forever — readable in seconds, defensible under audit.
Know who changed what.
Without asking.
Every mutation in the system is captured — actor, timestamp, before, after, and (when required) electronic signature. Pull a year of evidence in seconds. Walk into your audit with it ready.
- Tamper-evident. Append-only log with cryptographic chain of custody.
- Queryable. Filter by entity, actor, time range, action — in milliseconds.
- Exportable. CSV, PDF, or audit packet — ready for an inspector’s laptop.
Security
Built for the people who have to say yes.
Security and compliance are not bolted on. They are the substrate.
Tenant isolation
Per-tenant row-level security enforced at the database. Not application checks.
Encryption
AES-256 at rest. TLS 1.3 in transit. Tenant-managed keys on Enterprise.
Identity
SAML 2.0 · OIDC · SCIM. Okta, Azure AD, Google Workspace, Auth0.
Permissions
Role-based access with fine-grained permission strings. API keys with scope.
Backups
Point-in-time recovery. Cross-region replication on Regulated and above.
Residency
US-East and EU-West regions. Dedicated infra on Enterprise.
Integrations
Slots into the systems you already trust.
Single sign-on, identity providers, notifications, storage, and an API for the rest.
Customers
Quality teams who don’t get to be late.
We used to spend two weeks pulling evidence before every audit. With Qability, we open it and the evidence is already there.
The first QMS I have used that did not feel like punishment for working in a regulated industry.
Training assignment used to be a weekly spreadsheet exercise. Now it just happens — the moment a document is effective.
Pricing
Priced like software. Not a consulting engagement.
Per user, billed annually. No per-document fees, no implementation fees, no storage fees.
- Document control & versioning
- Up to 3 active workflows
- Real-time sync
- Email support
- Everything in Starter
- Training matrix & auto-assignment
- CAPA, Nonconformance & Change Request workflows
- Risk assessments & root-cause analysis
- Inspections, log books & forms
- AI sidecar
- Everything in Growth
- 21 CFR Part 11 e-signatures
- QC inspection & AQL sampling
- Supplier register, evaluations & portal
- SSO (Okta, Azure AD, Google)
- Audit log retention SLAs
- Everything in Regulated
- Data residency (EU / US)
- Dedicated infrastructure
- Premium 24×7 support
- Implementation accelerator
All plans include the audit trail, real-time sync, and the supplier portal. Suppliers are never counted as users.
FAQ
Answers, before you ask.
Yes. Electronic signatures capture identity, meaning, and reason at the moment of signing, with an immutable audit trail and tamper-evident records. Validation packages are available for regulated industries.
ISO 9001, ISO 13485, ISO 14971, FDA 21 CFR Part 820, 21 CFR Part 11, EU MDR, AS9100, IATF 16949, and FSMA. The document, training, CAPA, and audit-trail primitives are framework-agnostic.
Yes. ISO 14971 risk assessments and structured root-cause analysis — 5 Whys and Fishbone — are built in. Findings flow straight into a nonconformance or CAPA, so the analysis and the corrective action live on the same connected record.
Yes. Log books, gemba walks, and shift handovers are captured as form-driven field records with configurable edit windows that lock them into immutable, signed evidence. QC acceptance inspection uses AQL sampling plans (ISO 2859-1 / ANSI Z1.4), with admin-defined custom plans where you need your own tables.
Suppliers log in through a scoped portal with its own session and a reduced endpoint surface — they only ever see their own records, document requests, and assignments, never the main app. The supplier register, evaluations, and shared documents live inside your QMS, on the same audit trail and RBAC. Suppliers using the portal are not counted as billed users.
Most teams are running their first controlled document in under a week. There is no consulting-led implementation; templates and accelerators ship with the product.
Primary regions are US-East and EU-West. Data is encrypted at rest (AES-256) and in transit (TLS 1.3). Per-tenant database isolation via row-level security. Enterprise customers can request dedicated infrastructure or specific data residency.
Yes. SSO via SAML 2.0 and OIDC (Okta, Azure AD, Google Workspace, Auth0). SCIM provisioning available on Regulated and above.
Enterprise customers can deploy Qability in their own VPC. A managed cloud is the default and recommended path.
Per active user, billed annually. No per-document fees, no implementation fees, no storage fees. Suppliers using the supplier portal are not counted as users.
Yes. Starter is free forever for small teams. Growth and Regulated tiers include a 30-day trial of the full feature set.
Audit-ready by default.
Get a tenant, invite your team, and run your first controlled document in under a week. No implementation contract required.