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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

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

Managed Workflow Equals Quality

By Romeo Elias on Tue, Jan 02, 2018 @ 12:43 PM

Topics: Workflow Workflow Process Management Hosted Workflow Workflow and Business Process Management Compliance Workflow Managment workflow automation Regulations Document Control Quality Management Software Quality Management System CAPA QMS Customer Complaints quality regulatory FDA
3 min read

Are You still customizing your QMS by modifying source code?

By Romeo Elias on Mon, Dec 05, 2016 @ 11:21 AM

It is surprising how many companies today are solving their need to customize their Quality Management Software by modifying source code.  It is understandable why a company may want to customize a software to meet its unique business and quality processes.  However, software platforms have evolved so much that there shouldn't be a need to change or add code to the vendor platform.  Not only does this require expensive development skills and expertise, it also means that the company can no longer receive vendor upgrades to their platforms as they have branched out with their own custom solutions.

Topics: BPM Workflow Compliance Paperless Document Control Quality Management Software Quality Management System configurable CAPA Training Supplier Management Audits QMS nonconformance NCM Corrective Action Preventive Action Risk Management Change Management Customer Complaints