Quality management software
Quality management. Less paperwork.
Documents, training and quality processes in one eQMS. Built for pharma, biotech and medical device teams.
Security and validation, documented.
ISO 27001 Certified
Our information security management system is ISO 27001 certified. Supporting documentation is available in our Trust Center.
GAMP 5 Validated
Platform validation follows GAMP 5 guidelines for computerised systems in regulated industries.
Built to support your compliance with
ISO 9001ISO 13485GxPGDPRFDA 21 CFR Part 11One place for your quality processes.
Keep documents, people and actions connected. From the first review to final approval, everyone knows what comes next.
The right document. The current version.
Create, review and approve documents in one place. Keep version history clear and make approved procedures available to your team.
Explore this featureTraining
Assign training by role and track completion, from document reviews to on-the-job learning.
Events & complaints
Record deviations and complaints, assess their impact and follow up with an investigation.
CAPAs
Give every action an owner and a due date. Check whether the fix worked before closing the record.
Change control
Assess, review and approve changes with a traceable record of each decision.
A clear role for everyone.
Give each person the access and responsibilities their work calls for.
Organisation Admin
Admins can easily manage user access and record settings.
Action Owner
Action Owners can create, edit, review, and assess all types of records.
QA
QA users can perform impact assessments and provide closure approvals.
Operator
Operators can access documents & complete training assignments.
Built by people who work in quality.
QFacts started with the day-to-day work of quality managers: reviewing documents, following up on training and preparing for audits.
That experience shapes the product: clear workflows, practical controls and pricing that fits your organisation.
Meet the QFacts team
A few things worth knowing.
What is an eQMS?
An electronic quality management system (eQMS) brings quality documents, training and processes into one system. QFacts connects document control, events, investigations, CAPAs and change control so teams can track work and approvals together.
Who is QFacts for?
QFacts is for organisations of any size that want a lean, easy-to-use eQMS to support their compliance requirements. Quality teams, process owners and operators work in one system, with clear responsibilities and access controls.
Can we see QFacts before deciding?
Yes. Watch the product demo, or contact the team for a walkthrough using your quality processes as the starting point. Pricing is available on the website.
Let’s look at your quality process.
Tell us how your team works. We’ll walk through the parts of QFacts that matter to you.
Quality management, in practice.
Explore articles on document control, training and the day-to-day work of quality teams.