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Ensure Quality. Simplify Compliance.

When quality protects lives, you need clear structures and absolute reliability. ConSense brings all standards and regulatory requirements together in one system – transparent, secure, and tailored to your industry.

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Free of charge & without obligation

Over 1,000 companies from all industries use ConSense.

What matters to medical device and pharmaceutical companies.
How we make it work.

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Meet Regulatory Requirements and Prove Compliance

FDA regulations, GMP, MDR – the list is long, and every requirement must be documented without gaps. ConSense makes this simple with audit-proof archiving, 21 CFR Part 11-compliant e-signatures, and complete traceability of changes. Audit trails let you prove compliance with GxP standards in just a few clicks.


With ConSense, compliance becomes an effortless, verifiable part of your processes.

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Keep Documents Up to Date and Track Every Change

Manual document management is time-consuming and risky. Missing oversight can lead to costly errors – especially during audits. ConSense eliminates manual steps with automated approval workflows and secure electronic signatures, ensuring only verified, up-to-date documents circulate. Every change is traceable down to the smallest detail.


ConSense reduces effort, prevents errors, and guarantees audit readiness.

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Smooth validation and implementation

Introducing new software shouldn’t disrupt your operations. That’s why we deliver ConSense pre-validated. We also provide personal support, guiding you through validation and a structured, practical implementation of your new management system.


So you can unlock the full potential of your system from day one.

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Create an Accepted Quality Management System

Quality thrives on people – but new systems often face resistance. ConSense makes it easy to bring your team on board: users see only the information and processes relevant to their role, reducing complexity and boosting acceptance. Training on GMP, ISO & more can be centrally organized and documented, while automated notifications keep everyone informed and engaged. The result? A quality management system that isn’t just implemented, it becomes part of everyday work, actively lived and embraced across your organization.

ConSense creates a system that is clear, intuitive, and delivers real value – so quality becomes part of everyday work.

Key Modules for Medical & Pharma

Actions

Track corrective and preventive actions (CAPA) systematically and meet regulatory requirements.

Audits

Plan, execute, and follow up on audits efficiently.

International

Ensure consistent quality standards across borders.

ConSense Forms

Digitise forms and automate workflows for secure, paperless processes.

GxP

Meet all Good Practice requirements with ease.

Risk Management & ICS

Identify, assess, and mitigate risks proactively.

Qualifications

Manage employee qualifications and document training centrally.

Training

Plan, deliver, and document training.

Knowledge Hub (WIKI)

Make valuable knowledge accessible to everyone.

Your Benefits with ConSense

No compromises, no isolated solutions. As a quality management system for medical device and pharmaceutical companies, ConSense gives you everything you need to seamlessly integrate quality and compliance into your operations.

Compliance with less effort

Automatic monitoring of GxP requirements, templates, and integrated checks reduce workload and make audits stress-free.
Audit security through tamper-proof documentation

All quality-related documents, processes, and changes are archived with version control and full traceability.
Efficient, error-free workflows

Electronic processes and automated notifications accelerate operations and free up time for value-added tasks.
Data security and clarity

Employees see only what’s relevant to their role.
Ready to use

Industry-specific solutions and personal support ensure your system is operational from day one.
Free of charge & without obligation
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Your Solution Advisor

  • Get the right recommendation in just 3 minutes.
  • Automated analysis of your input.
  • Instant results, ready to view and export as a PDF.

In Three Steps to
Your New Management System

Getting Started with ConSense
1 Alignment We analyse your needs and tailor ConSense to your goals.
2 Implementation From planning to roll out, we guide every phase.
After the Rollout
3 Optimisation Continuous support for evolving requirements.

Always Well Advised

Our modular services
give you exactly the support you need when you need it.

Our Services

What Our Customers Say

Pflegeleitung

Zentrumsleitung Reusspark

“In our sector, where working with people is at the heart of everything, there’s always a fear of spending more and more time on administration. But once we started using the new system and saw the added value, ConSense QMS was quickly embraced by our employees. Today, we work much more efficiently.”

Roland Zieger

Kwizda Gruppe

“A key factor in our decision was the validation of ConSense GxP software in our company – something many other providers don’t offer.”

Macherey Nagel GmbH & Co. KG

“Quality is essential across all areas of our business. Complete function and process documentation was easy to implement with the tools provided by ConSense.”
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Strengthen Quality and Secure Compliance.

Book your free online demo now
and experience ConSense live in action.

Request a Demo
Free of charge & without obligation