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
- Paper, hybrid or digital? Where does your quality system really stand? Most quality teams we speak to call their system ‘partly digital’. That usually means Word templates on a shared drive, training in a spreadsheet and approvals by e-mail. It feels like progress. But it brings multiple versions, no reliable audit trail and no single view of what is overdue. We call it the hybrid trap. Getting out does not take a big project: get ready with QFacts from day 0 - without a long implementation trajectory. Which stage is your quality
- Before: SOP approved, training chased by e-mail. After: SOP approved, training assigned in real-time upon document approval. An SOP only works when the people doing the task know the current version. Yet approval is often where the chasing starts: list who is affected, update the training matrix, send reminders, collect wet signatures. In QFacts, QA decides on (re)training in the document approval step. Everyone in the linked job functions or departments get the assignment with a fixed due date and e-signed completion. New
- For years, we built workarounds for Quality Management Systems (QMS). Then we decided to build an eQMS instead. QFacts wasn’t started by a software company. It was started by Quality Managers. We worked with spreadsheets, shared drives and enterprise platforms. The first were too fragile for an inspection. The last were too heavy for a team of five. In the end, we built the system we wanted to use: lean workflows, an intuitive interface and including a full GAMP 5 validation. Swipe for our story. Which workaround did your team
- Your eQMS supplier says the system is validated. But can they show you the evidence? And how thorough is the evidence? Not every “validated” eQMS comes with proof. At QFacts, we validate the platform ourselves according to GAMP 5: risk assessment, specifications, testing and traceability, all documented and ready for your auditor. That means your team does not start from zero. You review our validation package, confirm QFacts fits your intended use, and get back to quality work. Swipe for five things a validated eQMS
- 5 signs your CAPA closed the record. But not the problem. A closed CAPA is not a solved problem. We've seen it many times: root cause documented, actions closed, signatures in place. Months later, the same deviation is back. Inspectors know this pattern. CAPA effectiveness is one of the first things they check. Swipe for the five warning signs, then hold them against your open CAPAs. Which one do you recognise? #CAPA #QualityAssurance #RootCause #GMP #ISO13485
- Your paper QMS feels free. It is the most expensive system you run. A paper-based quality system has no licence fee. That is exactly why its real cost stays invisible. It is paid in hours: printing controlled copies, chasing wet signatures, walking binders from desk to desk and rebuilding evidence before every audit. It is paid in risk: one outdated SOP on the shop floor is enough to trigger a deviation. And it is paid in speed: every change waits for a document, and every document waits in an in-tray. None of this shows up in a
- It’s the week before an inspection. Someone is flipping through a binder, looking for the cleaning checklist from last March. It turns out to be an old version of the form, with one signature missing and a “not OK” result nobody followed up on. Paper checklists are still behind many routine GxP activities: line clearances, equipment checks, cleaning, self-inspections. They’re a familiar source of avoidable findings. Since version 1.4.0, checklists are part of the QFacts eQMS: ✅ Controlled templates. Every checklist template is
- Congratulations to the entire Normec Synergy Health team on this milestone! It was a pleasure working together on the implementation. Wishing you every success with QFacts.
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