Skip to content
Qualio Home Page
Quality Management

Everything you need to run quality.
Live in under 60 days

Policies and procedures, with the training that follows them. CAPAs, NCRs, deviations and complaints. Change control, risk and suppliers. One system the whole company uses, not just quality.

Book a Demo
Qualio My actions screen: documents to approve, training due, open CAPAs, change requests and supplier reviews in one list

700+ life sciences companies

VerantosTrivium VetAvectasiMixBiofidelity
4.7/5 on

Without Qualio

Nothing is missed until someone notices

A revised SOP means chasing sign-off, then chasing everyone to retrain, then working out who is still on the old version. A CAPA slips because the reminder was a person.

Approvals sit in inboxes

Nobody can see where a document is stuck

Retraining nobody triggered

The SOP went live. The training did not follow.

Overdue actions nobody flagged

The due date lived in someone's head.

THE STAKES

Keeping it all in sync is a full-time job, and none of it is quality work.

With Qualio

Nothing is missed, because Qualio notices

Approve a revised SOP and the training reassigns itself. A CAPA links to the SOP that caused it and escalates before it goes overdue. Keeping it in sync is Qualio's job, so your team's time goes back to quality.

The Results

$130K

Spend eliminated.

Neufit

50+

Audits managed.

eClinical

99%

Reduction in quality admin time.

Akadeum Life Sciences

Document management

Control the full document lifecycle

Create, review, approve, and distribute controlled documents from one place. Track changes and comments live in the document, so review happens in the system, not in email.

  • Automated version control with full history
  • Configurable review and approval workflows with electronic signatures
  • Collaborate inline, no check-in/check-out
  • Procedures and templates for your regulations, about 90% written. See QMS templates.
See document control
Qualio document library listing controlled SOPs and procedures with their type and version

Change control

See what a change touches before you sign it

Initiate change requests, assess impact across documents, training, processes, and design controls, and route through configurable approval chains. When a change is approved, affected documents and training assignments update automatically.

  • Impact assessment across documents, training, design controls, and risk files
  • Configurable multi-level approval chains
  • Automatic downstream updates on approval
  • Full audit trail of every change decision
See change control
Qualio change request with the description, reason for change and impact assessment of the affected documents

Training management

Retraining follows every revision

When a revised document takes effect, everyone who trains on it is assigned the new version, and Qualio tracks who has read it, who has passed the quiz and who is overdue.

  • Trigger assignments and reminders automatically
  • See completions and overdues in real time
  • Report the training matrix the way auditors expect
See training
Qualio organization training: 94% training completed, with completions, due and overdue counts per document

Hear from our customers

EvoEndo

“Qualio helps me sleep better at night. Having that structure for everyone to work within is essential for us to really succeed this year in getting onto the market and staying compliant.”

Heather Underwood

CEO, EvoEndo

Read story
Heather Underwood
30 Technology

“I contacted Qualio in November. We went live mid-December. We had all users in by January. And we had our ISO 13485 certification in July. Without Qualio, we'd never have done that.”

Karen Hue

Head of Quality & GxP Compliance, 30 Technology

Karen Hue
AGADA Biosciences

“My confidence in being audit-ready is dramatically improved… one organized system that’s a lot easier to maintain.”

Chris Rice

Senior Quality Assurance Manager, AGADA Biosciences

Read story
Chris Rice

CAPAs, NCRs & deviations

Event flows that fit your process

Capture the event, investigate root cause, assign corrective actions, verify effectiveness. Nothing falls through the cracks, because nothing has to live in a separate spreadsheet.

  • Configure CAPA, NC, deviation, OOS, complaint and SCAR flows to your process, with your fields, steps and approvals
  • See trends by product, site, supplier or root cause before the auditor does
  • Escalate before an action goes overdue, not after
  • Run internal audits as events, each finding a task or a CAPA. See audits.
See CAPA management
CAPA-034 moving from the quality event through root cause, corrective action and effectiveness check, with its audit trail

Supplier management

Qualify, monitor and audit suppliers

Link every deviation, complaint and SCAR to its supplier, so supplier performance is measured on what happened.

  • Rank suppliers by risk and schedule audits to match
  • Link every event to its supplier, so supplier performance is measured on what actually happened
See supplier management
Qualio supplier record for Amazon Web Services: risk level, supplier details and approvers

AI and Copilot

Hand over the admin, keep the approval.

Copilot tells you who is trained on the new revision, drafts the change control from the revised procedure, builds the training quiz from the SOP, and raises the deviation from a description of what happened. Every output cites its source and waits for your approval. Everything you approve here is already evidence for Compliance Frameworks.

ISO 13485 gap opened by the Compliance Agent, with the Copilot drafting a change to SOP-59 that waits for QA approval

Company-wide value, without a training project

Run quality in one system, today

Book a Demo
#1 Most Implementable eQMS on