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In manufacturing today having a structured compliance system to control the systems within your facility has become an essential requirement. In the last 20 years compliance systems for all aspects of manufacturing have expanded from the initial ISO 9001 to include ISO 17025, TS16949, and AS9001 for quality along with ISO 14001 for environmental and expanded health and safety requirements or ISO 18000. Given all of these requirements there is a need to ensure you run your compliance system instead of the system running you.
One of the main challenges in managing regulated compliance systems is to ensure items and issues get dealt with in a timely manner. Tasks such as getting approvals on documents or ensuring a CAR is processed through root cause analysis to action taken and then verification can be a very time consuming effort which usually involves various follow up calls and emails to get this accomplished.
Another area that causes endless effort is keeping track of regularly scheduled tasks such as annual document reviews, equipment calibrations and scheduling and completing audits. Paradigm 3 is designed to alleviate all of these time consuming mundane tasks. This will then enable you to focus on the main benefit of having a structured quality program being able to review your system knowing it is in control and look for areas of improvement.
The Interax Group in conjunction with Paradigm 3 Software has extensive experience in the manufacturing industry having assisted numerous manufacturing facilities to implement our software enabling them to automate many of the time consuming tasks in their current systems.
To enable you to manage you system Paradigm 3 provides a suite of tools to assist you including:-
Document Management – Management of 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 from creation to scheduled reviews.
Incident/CAPA/Customer Complaints - 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.
Resources Cabinet Module – This module is mainly used to manage calibration and maintenance of equipment and vendor assessment and tracking informing assigned personnel of scheduled activities via action items to assigned personnel. Contained within Paradigm 3 is an action item escalation feature which if set will inform an area coordinator or manager if assigned dates are passed without action. This can be particularly useful in the case of calibrations Along with the aforementioned applications this module can also be used where any database forms are utilized.
Training Management Module – The module manages and tracks required 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.
Feel confident your systems are in control and you are in compliance with the requirements of your registered system user friendly Paradigm 3 software.
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