40+ jaar expertise in laboratoriumapparatuur
Service & onderhoud door gecertificeerde specialisten
Validated temperature monitoring for the pharmaceutical sector
Dyzle specialises in validated temperature monitoring, temperature mapping and GxP services. As a partner in the Pharma Alliance, Dyzle ensures your quality management is always in order.
Dyzle is the specialist in validated temperature monitoring for organisations working with medicines, vaccines and other temperature-sensitive products. Through a combination of accurate hardware, modern cloud software and personal service, Dyzle helps clients keep their quality management structurally in order.
Dyzle's core values are goal-oriented, pragmatic and reliable. These values reflect how they work with clients: solutions that fit seamlessly into business processes and continue to add value after implementation.
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Dyzle offers three core solutions that together form a complete compliance programme for pharmaceutical organisations.
The Dyzle monitoring system consists of accurate sensors that measure real-time temperature, humidity, pressure and door statuses. Data is transmitted via a secure connection to redundant servers, making data loss structurally impossible. The system is scalable: from a single cold room to a worldwide network of storage locations for vaccines and medicines.
With a temperature mapping study, Dyzle accurately charts the temperature distribution in rooms or vehicles. Hot spots, cold spots and other critical control points are identified and reported in a clear mapping report. This report provides evidence that a space or vehicle is suitable for the storage or transport of medicines in accordance with GDP guidelines.
For organisations operating within GAMP, GMP or GDP environments, Dyzle provides full GxP services around temperature monitoring. This includes drafting a User Requirements Specification (URS), performing qualifications (IQ/OQ/PQ), computer system validation (CSV) and periodic recertification. This keeps the validated status of the monitoring system intact, even after software updates or infrastructure changes.
Direct visibility into all critical measurement points via the clear software interface. Alarms are sent immediately upon deviations, so you are never too late.
Data is transmitted via a secure connection to redundant servers. Once stored, it is impossible to lose data.
Dyzle monitors the temperatures of medicines and vaccines across the globe. The system scales effortlessly from a single cold room to an international network.
Complete GxP documentation, including mapping reports and validation dossiers. Always ready for inspection by regulatory authorities.
Dyzle guides periodic recertification so the validated status remains intact, even after software updates or infrastructure changes.
Solutions that fit seamlessly into your business processes. Dyzle thinks along with you and continues to add value after implementation.
The refrigerators, freezers and laboratory equipment supplied by Poly Temp Scientific require reliable monitoring and periodic validation. Dyzle provides exactly that. Together, both parties form a complete solution for clients who want to arrange equipment and compliance in a single process.
Within the Pharma Alliance, Dyzle works closely with partners such as DKC Totaaltechniek for cold and freezer rooms and Yxion for GxP consultancy. This creates an integrated approach in which each discipline is covered by a qualified specialist.
Organisations working with medicines, vaccines and raw materials are required to demonstrably monitor and document storage and transport temperatures. This applies to GMP production environments as well as GDP-certified storage facilities and distribution networks. Dyzle offers a solution that complies with all relevant guidelines: EU GMP Annex 1, GAMP 5, ICH Q10 and the EU GDP guidelines.
Do you have questions about temperature monitoring for your laboratory equipment or storage facilities? Get in touch for a no-obligation consultation.
Dyzle is one of fifteen specialised partners in the Pharma Alliance. Discover the full network.
Do you have a project involving multiple disciplines? Our advisors are happy to explain how the Pharma Alliance can support you with an integrated approach.
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