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14 min read

Evaluating Total Cost of Ownership for Quality Management System Software

By Paul Dionne on Wed, Nov 25, 2020 @ 12:34 PM

 Comparing software packages is hard. 

Topics: Quality Management Software Quality Management System QMS quality eqms on-premise hosting Cloud based hosting total cost of ownership professional services
3 min read

Intellect on AWS GovCloud

By Selim Ozyel on Thu, Nov 12, 2020 @ 04:16 PM

As the world transitions toward agile, decentralized cloud computing, numerous US federal agencies have aligned around a stringent set of common standards and practices for security and risk assessment known as FedRAMP.

Topics: Cloud Quality Management Software Quality Management System QMS Risk Management Cloud based hosting on-cloud solution eqms software amazon web services govcloud FedRAMP security
3 min read

Staying HIPAA Compliant with QMS Software

By Selim Ozyel on Wed, Oct 28, 2020 @ 04:54 PM

For many companies in FDA regulated industries, including pharmaceuticals, medical devices, labs and life sciences, compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a critical requirement.

Topics: Compliance Quality Management Software Quality Management System CAPA QMS quality challeneges HIPAA Compliance HIPAA cyber-security
7 min read

Build or Buy? How to Buy QMS Software That Meets All Your Needs

By Peter Hargittay on Fri, Aug 28, 2020 @ 02:18 PM

The build vs. buy dilemma isn't new to businesses considering investing in a quality management system. After all, they often have very specific needs from their QMS solutions (depending on the regulations that apply to them, their desired process automation maturity and manufacturing velocity, their monitoring and analysis expectations, and their unique documentation and data processes, among dozens of other things).

Topics: Compliance Quality Management Software Quality Management System configurable QMS quality eqms eqms software configurability
4 min read

8 Mandatory Elements of a QMS System

By Peter Hargittay on Wed, May 27, 2020 @ 12:48 PM

A Quality Management System (QMS), is a set of processes that are implemented to ensure that business leaders meet FDA, ISO, and other global GxP regulatory requirements to help deliver better and safer products and to increase productivity. A successful QMS should be configurable and adapted to meet the needs of your business, including manufacturing, medical device services, aerospace, pharmaceuticals, nutraceuticals and so many more.

But what should I look for in a Quality Management System?

An effective QMS framework not only offers advanced analytics, to help better understand data, it enables users to make more informed decisions and improve productivity and can be properly executed if your business has these 8 robust Quality Management System apps.

Managing NonConformance (NCM)

Managing NonConformance (NCM) is an integral part of an organization’s continual improvement plan. Intellect’s QMS Platform enables organizations to capture, track and maintain accurate, auditable nonconformance records through a centralized database to have transparency for departments, sites, or locations. This allows organizations the ability to exceed audit, nonconformance, and corrective and preventive action requirements of common standards including ISO 9001, ISO 14001 and OHSAS 18001.

Topics: Document Control CAPA QMS Risk Management