Orcanos QMS: Regulation Compliance & Governance Engine

August 7th, 2017 Posted by Zohar Peretz( ) Document control, IEC 62304, IEC60601, ISO 13485, ISO 14971, regulation compliance

Orcanos is about to launch its QMS-Regulation-Compliance engine as part of Orcanos integrated ALM and Quality Management Software System.

Abstract

Compliance best practices lie at the heart of all standards-based regulations and good quality management, such as ISO 14971, IEC 62304 and ISO 13485. However, it is a challenge to keep compliance without electronic QMS, or using traditional ALM tools, as most of them are R&D driven, and lack the support of the quality management software system. Compliance remains a leading concern for regulated industries such as Medical Device, Pharma and automotive.

Orcanos QMS Compliance engine

The powerful new capabilities of Orcanos Compliance Engine would simplify the way companies govern and control quality and regulations, and will provide a “Virtual Auditor” that would scan the project data in respect for specific industry regulation, and quality best practice, such as compliance with ISO 14971, IEC 62304 and ISO 13485 and more.

Orcanos QMS Compliance Engine is a flexible tool that allows companies define any regulation in a simple Excel or Google Sheet, defining the standard, section, classification in case of medical device (CLASS I, II, III), Remediation, and many other parameters, ans then import these regulations into Orcanos ALM and QMS platform and connect it to their projects records.

Orcanos QMS Compliance Engine then scans project data based on the specific regulations, and specific logic attached to it, and shows the faults in a graphical presentation. Together with Orcanos dashboard and notification mechanism we provide quite a good control and monitoring platform

Defining a compliance audit item

Define any compliance audit, setup and customize each compliance item

Compliance Audit

Running a compliance audit check

This is an example of an “Virtual Auditor” that inspects the compliance of specific product with the ISO 14971.

Running Compliance Audit Check

 


About the author, Zohar Peretz

Zohar has 18 years of experience in leading software development products, at leading software companies and startups. Using his vast experience in software development, Zohar has identified the need for a holistic solution for R&D departments, and together with Rami and a small development team, they established Orcanos ALM in 2005.

Since then, Orcanos software has evolved to other domains such as quality control and specific industries, such as medical device.

Zohar holds a BA degree in Industrial Engineering.

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