Overview
QFacts provides an intuitive, ready-to-use eQMS platform with document control, training, and CAPA management for regulated companies. The platform is ISO 27001 certified, GAMP 5 validated, and designed to support compliance with ISO 9001, ISO 13485, GxP, GDPR, and FDA 21 CFR Part 11.
Key people
In the news
- Most quality issues don't happen overnight. They build up slowly because of habits that slip through the cracks. Here are 5 Quality Management best practices that separate the companies who struggle during audits from the ones who sail through them. 👇 📄 Master your document management Version chaos and uncontrolled copies are a few of the most common QMS failures. Make sure every team member always works with the latest approved version, and that outdated documents are removed from circulation immediately. If people aren't
- There's a question every quality manager should be able to answer in 60 seconds: "Are we compliant right now?" If the honest answer requires opening three spreadsheets, e-mailing four colleagues, and checking two SharePoint folders: You don't have compliance tracking. You have compliance reconstruction. The difference an eQMS makes: ❌ Status buried in spreadsheets → ✅ Live dashboard, always current ❌ Manual e-mail follow-ups → ✅ Automated alerts through one system ❌ Deadlines missed until audit → ✅ Every action traced live ❌
- What exactly is an eQMS?" If you've heard the term thrown around but never got a straight answer, here it is. An eQMS — electronic Quality Management System — is software that replaces the tangle of paper binders, shared drives and endless Excel files that most quality teams still rely on. Instead of chasing documents and hoping you've got the latest version, everything lives in one connected, always-current system. Here's what that actually looks like day to day: ✅ Documents & SOPs — version-controlled, approved and
- Quality audit preparations, two ways: Without an eQMS: ❌ Map scope across spreadsheets and tribal knowledge ❌ Hunt for the "real" latest version of every SOP ❌ Build the internal audit checklist from scratch ❌ Chase CAPA owners over email ❌ Hope your team remembers the process With an eQMS: ✅ Open the process map and risk register ✅ One version. Always current. Always approved. ✅ Run the audit workflow ✅ Live dashboard, every open action visible ✅ Training records prove competency Same five steps. Five times less effort.
- Trust. 🔒 Why do companies trust QFacts with their quality management? In quality management, there's no room for guesswork. That's why a growing number of companies — across pharma, manufacturing, and beyond — rely on QFacts as their eQMS. Here's what makes the difference for our customers: ⚡ Speed & Efficiency: No more manual, repetitive tasks. QFacts automates the heavy lifting so your team can focus on what actually matters. 🔗 Easy Integration: Ready to use from day one. QFacts fits seamlessly into your existing processes — no
- Your eQMS holds some of your most sensitive data. But is it actually safe? Think about what lives inside your quality system: detailed process instructions, CAPAs, supplier records, batch documentation, customer complaints, intellectual property. Now ask yourself: if your eQMS vendor were breached tomorrow, what would happen to all of it? For too many Quality Managers, that's an uncomfortable question. And here's the truth: in a regulated environment, data security isn't a "nice to have." It's part of the mandatory compliance
- Quality" used to mean control. Tomorrow's best quality teams will be defined by clarity, speed, and foresight instead. ⏭️ Three shifts that change everything:
- Audit anxiety. For some Quality Managers, a regulatory inspection or customer audit comes with sleepless nights, long working days and weekend sessions, endless searches for paper documentation... Sound familiar? Here's the truth: audit stress is a symptom, not the problem. The real problem? Your quality system isn't audit-ready by default: ✅ Every document automatically up-to-date and version-controlled ✅ Complete audit trails built in with full traceability ✅ Non-conformances tracked and closed systematically ✅ CAPAs closed on
Something wrong or missing? Send an update. Fixed within 24 hours.