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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

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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.

Complaints Management

Complaints Management software is needed for customer retention, compliance with industry regulations and avoidance of potential product liability lawsuits. Quality, compliance, safety, efficiency, and costs are impacted in addition to poor communication without a proper QMS in place. Intellect QMS includes change management, automation, version control, and workflows to communicate, acknowledge, and then implement any requirements.

Change Management

Change Management software is imperative for closed-loop quality and requires automation, version control, and workflows. Intellect QMS integrates with any enterprise system, so full transparency is included in the change management process. The submission of change requests and control plan revisions can be included at any point in production.

CAPA

CAPA-Status

CAPA (Corrective and Preventive Action) and product registration tracking are standard features to allow implementation of corrective and preventive actions. This will meet compliance with industry regulations including GMP, ISO 9001 and 14001, TSCA, REACH, etc. CAPA process workflows provide a controlled environment and reduce the risk of repeat issues by ensuring that defined CAPA solutions and processes are met.

Document Control Management

Doc Control

Document Control/management organizes all documents into a centralized database with approval workflows and audit trails. This eliminates document redundancy, reduces the risk of manufacturing products with out of date SOPs, and creates efficiency in organizing documents.

Supplier Quality Management

Supplier Quality Management manages the process of qualifying, selecting, and monitoring suppliers and supply chain partners. Other requirements are supplier qualification workflows and tracking systems for supplier non-conformances and CAPA. Intellect QMS offers the flexibility and configurability to adapt to company specific business processes, requirements and needs. This allows organizations to define, track, manage, and report actions.

Audit

intellect audit management system

Audit Software reduces risk by enforcing consistent and harmonized processes while securely managing all information in a centralized system. In addition, it facilitates compliance with global government regulations and industry standards providing management the data needed to evaluate audit system effectiveness. It also provides auditors authoring tools required in the field.

Employee Training

Employee Training Software creates a single interface to develop and manage training initiatives organizationally. This allows enterprises to maintain a complete inventory of employee education levels, job descriptions and certification records. This will maximize the effectiveness of developing employee skills internally. Intellect QMS keeps employee certifications up-to-date as a full employee life-cycle enterprise management system.

How Intellect QMS System Can Help You

Intellect is an industry leader in extremely configurable QMS and no-code platform software, and Intellect can help your business achieve faster implementation time, robust out-of-the-box QMS capabilities, and unique process requirements.

Adapt to changing business requirements and regulations by easily modifying and building new business apps to address a wide variety of business needs.

If you’d like to learn more about Intellect QMS 4.0, request a free demo today.  

Peter Hargittay

Written by Peter Hargittay

Peter Hargittay is the Chief Marketing Officer (CMO) and VP of Corporate Development at Intellect. Peter is responsible for rebranding the company as Intellect from Interneer and for positioning the company for significant growth. Peter joined Intellect in 2013, and is responsible for corporate, product, and online marketing, business development through the Intellect partner channel, demand generation, sales enablement, and go-to-market strategies. Peter has more than 15 years of experience in building successful software and services businesses. Prior to Intellect, Peter served as the VP of Marketing and Sales Operations at Arise Virtual Solutions, and previously held executive marketing roles at Aegis, PeopleSupport, Intersil, and FileNet. Peter received both his BA in Economics and MBA from California State University, Fullerton.