PARADIGM 3: ISO 13485 DOCUMENT CONTROL SOFTWARE

Paradigm 3 compliance and document control software for medical device manufacturers provides complete confidence in your ability to manage your ISO 13485 and FDA’s 21 CFR Part 11 electronic signature requirements. With Paradigm 3 ISO 13485 software managing your system no longer has to be a daunting task, numerous tools assist you in meeting and managing those requirements.

Targeted action items are delivered via email ensuring such tasks as, document control, calibration, training and CAPA are understood and completed on time providing transparent validation of ISO 13485 system.

ISO 13485 Software

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Paradigm 3 delivers a completely easy to use suite of four module applications which enable you to meet the requirements of the most stringent regulations.

Controls all aspects of document creation, review, approval and release. Our targeted action items ensure a seamless work flow through the various phases of a document life cycle including notification of scheduled reviews and real time revision logs.

Our improvement generator module provides highly flexible processing and reporting on all requirements where an investigative workflow is required. Ensuring various steps are carried out and appropriate personnel are informed in a timely manner. Paradigm 3 not only informs persons of required actions it also allows instant access to status of individual or all outstanding issues.

This module is mainly used in manufacturing for managing calibration and maintenance requirements, approved vendor tracking, document change request along with such tasks as MSDS sheet management. We feature action item notifications of assigned tasks along with the ability to automatically escalate those action items should they not be completed on time. Should you get external information such as photographs or calibration certificates these can be easily attached and integrated into the records with the paper clip feature.

The module manages and tracks required education and training. Our exclusive search function allows you to search aspects of training such as who is competent to perform a certain task to what training is due next month. Action items notify applicable personnel indicating clearly what training is required, where it will be held and when. Keeping your whole training matrix in control and proactive.