Quality assurance & compliance

In an environment where you are responsible for every treatment, pharmaceutical quality assurance is becoming the common thread running through your organisation. It combines patient safety, regulatory compliance and operational performance: three pillars that you need to reconcile on a daily basis.
Between patient safety, regulatory requirements and the reputation of your establishment, pharmaceutical quality is the foundation of your performance. QCRx® simplifies this mission by automating control and securing documentation.

Standards in force in the EU

To give practical expression to your quality commitments, you rely on a dense regulatory framework. Knowing these references – and proving your compliance – is a prerequisite for authorisation to make your preparations available.
  • BPF/GMP & BPP : good manufacturing and preparation practices
  • ISO 9001 / 13485 : quality management & medical devices
  • ANSM (France) – EMA (Europe) : control authorities
  • RGPD & hébergement HDS : health data protection and hosting

QCRx®: instant compliance leverage

Faced with the complexity of standards, you need a tool that can transform legal obligation into operational advantage. That’s the promise of QCRx®.

Thanks to its automatic analytical control and its compliance report issued in real time, QCRx® secures each batch and effortlessly provides the documentation expected by inspectors.

See the QCRx® in action.

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Integrated traceability and documentation

Beyond control, transparency is your best argument. Complete traceability protects your teams, reassures the authorities and enhances the quality of your care.

Each control is Time-stamped, signed, archived. Data is encrypted and accessible for your internal or external audits, ensuring end-to-end drug compliance.

Audits, certifications and compliance of medicines

Inspections can be challenging; they become a formality when your processes are marked out. Icones Services positions itself as your daily partner to prepare, simulate and succeed in these regulatory meetings.

We support your teams: personalized checklists, mock audits, feedback from already certified sites, and continuous updates as soon as new regulations come into force.

Measurable results

A system’s value is measured by its metrics. Here are the benefits our customers have seen after integrating QCRx®:
  • -50% time spent on quality documentation;
  • 99% compliance rate during inspections;
  • Zero critical deviations reported since the implementation of automated control.

Be supported in your quality approach

Ready to turn your regulatory obligations into a real performance lever? Let’s discuss the best strategy for your institution.

See the QCRx® in action.

Schedule an online demonstration:
REGISTER