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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
3 min read

Embrace the Advantages of Digital Document Management

By Peter Hargittay on Thu, May 30, 2019 @ 11:11 AM

Remember that time you were working from home and needed an employee to send you a file? Only they had to dust off a fax machine in order to send it, because it was a physical file. You know, the kind that’s stored in a file cabinet.

Topics: digital business Document Control Quality Management Software Quality Management System QMS digital transformation quality challeneges quality processes digital document management
3 min read

6 Tips to avoid 483 letters

By Peter Hargittay on Wed, Nov 28, 2018 @ 02:40 PM

 

Topics: Document Control QMS
3 min read

3 Compliance Issues That Can Be Solved By Automation

By Romeo Elias on Mon, Jul 16, 2018 @ 01:31 PM

 

Topics: Compliance workflow automation business automation Document Control CAPA automated solutions mobile compliance FDA compliance iso compliance laboratory compliance
3 min read

The Effects of Document Control on Certain Industries and Risk Management

By Romeo Elias on Thu, Mar 15, 2018 @ 09:41 AM

Topics: Document Control Quality Management Software Quality Management System Risk Management quality