Smart software for better quality in healthcare.Ensuring continuity in a highly controlled environment
In a laboratory, it is essential to have a quality management system in place, as you must comply with strict quality criteria and legislation and regulations. Procedures and experiments are carefully recorded, any deviations are critically examined, and periodic checks and inspections reveal any areas for improvement. In addition, you must demonstrate compliance with standards such as ISO 15189 and ISO 17025. A quality management system ensures continuity and allows you to better manage risks.
Zenya helps you with this. You gain control over quality with one reliable, integrated solution. With Zenya, your laboratory complies with all requirements in the field of quality and risk management.
Zenya in practice
Does your medical laboratory need to comply with ISO 15189? If so, high standards are set for quality and competence. Among other things, it is important to have document management, staff authorisations, equipment management and the improvement cycle in order.
Zenya supports laboratories in complying with ISO 15189 by digitally securing processes and documentation relating to quality and patient safety. With Zenya, you can manage protocols, procedures and SOPs centrally and version-controlled, including read confirmation. Deviations and complaints are recorded in a structured manner and followed up according to established CAPA workflows. Risk management and internal audits are also easy to plan, execute and monitor.
There are many devices in use in a laboratory. These include microscopes, incubators, autoclaves, stirrers and hot plates. It is important that these function properly, but managing and maintaining all devices and machines is a lot of work.
Zenya makes this process simple and reliable. Using the Zenya Card file, you can register equipment, including accompanying manuals, maintenance and calibration schedules. Employees can use a QR or NFC code to directly access the correct document or report form, for example in the event of a malfunction. That malfunction can be automatically linked to a deviation, ensuring a smooth follow-up and that nothing is overlooked.
When conducting laboratory research, you want the results to be as accurate and reliable as possible. That is why it is important to know the origin of the results: what materials were used, what samples were taken and what process steps were taken.
Zenya enhances traceability within laboratories. All process steps, measurement values, document versions and assessors involved are recorded in a structured manner. This creates a complete and reliable audit trail, enabling laboratories to easily demonstrate who did what and when, which is exactly what is needed for evidence and successful completion of audits.
Change management is important in laboratories because every change — whether it concerns a method, device or work instruction — can affect the reliability of results. With good change management, every adjustment is carefully assessed, approved and documented before it is implemented. This ensures quality and compliance with accreditation requirements such as ISO 15189 or ISO 17025.
Zenya offers control over change management. With our solution, change requests are processed step by step, including multi-level approval and automatic recording of every action. This keeps the entire process clear, traceable and fully audit-proof.
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Zenya is more than software. We help you implement smart solutions within your organisation—whether you’re just getting started or looking to go deeper. Our consultants are here to support you with guidance, advice, and training.
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