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NOLATO Meditech

Quality requirements and adaption to the process industry

BACKGROUND

Nolato MediTech is part of the Nolato Group, which develops and manufactures polymer products and systems in close collaboration with leading medical technology and pharmaceutical companies. Nolato MediTech’s customers place very high demands on the quality of all work processes, including those pertaining to facility and machine maintenance. Where applicable, ISO 13485, ISO 9001, ISO 14001 standards must be met. Nolato MediTech is also approved by the Federal Drug Administration (FDA).

MISSION

Nolato MediTech needed a proven maintenance system that could handle both facility and process-related items. One of the conditions was full control of system updates and consistent traceability to ensure that customer quality requirements could be maintained. Work order management was to be primarily handled using mobile tools.

WHAT WE DID

The maintenance system was supplemented with electronic signatures in order to track changes to individuals and with functionality for managing uptime counters on Nolato MediTech’s machines. To achieve better control of test and version updates, the system was moved to the company’s own servers, and in addition to the live environment, a test environment was created in which to make risk assessments and verify the changes made to new versions.

RESULTS

In addition to a simpler approach with V3i’s basic features, job traceability has been enhanced and the work for those executing the jobs has been simplified. A lot of previous manual work has been replaced by digital registration, thus reducing the number of sources of error. Nolato MediTech has received a quality-assured system that meets the demands of the customers.

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