IQMH ISO 15189

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iqmh-iso-15189

The Right Tools…

The Ontario Lab accreditation program was developed in 2003 and has since been rolled out across the province under the auspices of IQMH. Paradigm 3 has played a central role in enabling hospitals and labs to automate their IQMH 15189 plus system. In fact most of the organizations that have software for compliance utilize our package. IQMH is now also involved in implementing ISO 15189 plus in other provinces across Canada such as Newfoundland were all major labs utilize our software.

Paradigm 3 Compliance and Document Control software provides tools to develop, control and maintain processes. Our powerful Targeted Action Items ensures you are confident of being in compliance at all times and our flexible reporting system allows you to extract the information your need to continually improve.

Paradigm 3 takes the challenges of IQMH ISO 15189 plus and wraps them into one simple solution.

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Some of our Valued Customers

Document Control

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 software will enable you to meet all the requirements of CFR 21 Part 11 including IQ and OQ scripts performed at installation.

Nonconformance/ 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.

Training

Manages and tracks required education and training. Integrated into our software is the ability to apply test and questionnaires associated with any task or documents. These automated assessments greatly reduce the effort in showing competence h. 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.

Flexible form design

Complete flexibility to design forms for collecting test results data in our Records Module. These forms enable custom searching and analysis of results found. The system also allows results to be exported to required forms with appropriate logos to send to customers or vendors as required These forms can be used for any purpose and can be integrated into legacy software.

Internal Audit Management

We provides control, notification, and tracking over all facets of audit management. Our software features reminders of dates for review. Tracking of corrective actions assigned for critical issue identified, instant notifications are sent to all designated parties through all investigation and resolution phases.

Approved Vendors

The Paradigm 3 Approved Vendors database provides an extensive solution for monitoring and approving your vendors’ performance. In addition to keeping records of vendor status, this dynamic tool notifies you of scheduled reviews and score vendors directly within the database record.

Calibration Maintenance Management

Fully flexible forms to ensure the system is compatible with all types of equipment and instrument calibration or maintenance notifications. Calibrations are made easy with automatic notifications that can be scheduled for distribution according to each piece of equipment and their associated calibration/maintenance dates. auditors.

Inventory control

Utilizing our Records Module keep track of inventory and date sensitive reagents. Targeted notifications can be set up to enable appropriate personnel to receive action items should dates become close to expiry. To enable appropriate actions to be taken.