News

News & Updates

Product updates, new tools, regulatory news, and deep dives into every part of the MoniDoseQMS platform. Search or filter to find what you want to learn.

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Spotlight of the dayPerspective1 June 20266 min read

Quality management is really about patient safety

Behind every quality record is a person who will use the product. This is why we built MoniDoseQMS — and why we treat quality not as paperwork, but as the system that keeps patients safe.

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Feature1 June 20264 min

Deleted by mistake? The 90-day recycle bin that protects your records

In a regulated quality system, an accidental deletion should never be a disaster. Here is how the MoniDoseQMS recycle bin keeps your documents and records recoverable for 90 days.

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Feature1 June 20264 min

Regulatory news, built in: stay ahead of the authorities that matter to you

Regulation never stops moving. MoniDoseQMS brings the latest updates from the authorities you care about directly into your quality system — so staying current is part of the workflow, not a separate chore.

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Feature1 June 20264 min

My Tasks: never lose a quality action across the platform

Quality work is full of small actions that cannot fall through the cracks. My Tasks gathers everything assigned to you — from any module — into one accountable list.

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Feature1 June 20264 min

Events: coordinate quality work and keep your team aligned

Audits, reviews, training sessions, deadlines — quality work runs on a calendar. The Events feature keeps those moments organised, linked to the right records, and shared with the right people.

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Feature1 June 20264 min

Your compliance health at a glance: the MoniDoseQMS dashboard

How healthy is your quality system right now? The dashboard answers that in a single view — what is open or overdue, and where your compliance stands across the areas that matter.

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Feature1 June 20264 min

Your account, your control: two-factor security and data ownership

Strong security is not only about the platform — it is about your account. Here is how MoniDoseQMS puts control of your access and your data in your hands.

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Insight30 May 20266 min

One platform, not fourteen tools: why a unified eQMS matters

Disconnected quality tools do not just slow teams down — they create the exact gaps that audits and recalls are made of. A unified eQMS closes them by design.

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Guide29 May 20267 min

From idea to market: the regulated product journey, end to end

Taking a medical product from concept to launch is a long, regulated road. Here is the whole journey — and how one platform carries you through every stage of it.

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Compliance28 May 20268 min

How MoniDoseQMS maps to ISO 13485, EU MDR, and FDA QMSR

Compliance is not a badge — it is a set of specific requirements that have to be met with specific evidence. Here is how the platform maps to the standards that matter, clause by clause.

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Product27 May 20267 min

Inside the workflows: document control, CAPA, and change control

A feature list tells you what a system has. A workflow tells you what it is like to actually use. Here is how the three workflows at the heart of every QMS run inside MoniDoseQMS.

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Compliance26 May 20266 min

Trust by design: 21 CFR Part 11 e-signatures and a tamper-evident audit trail

In regulated quality, a record is only as good as your ability to prove it has not been altered. Here is how electronic signatures and a hash-chained audit trail build that trust into the platform.

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Security25 May 20266 min

Security and data residency: protecting regulated data in the EU

Quality data is some of the most sensitive data a company holds. Here is how MoniDoseQMS protects it — from encryption and access control to EU data residency and deployment choice.

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