The Urge to Converge: Combine Your Quality & EHS Management Systems
Industrial Safety & Hygiene News Magazine, September 2012, page 52
Systems that have a similar taxonomy in terms of core functions and applications are slowly converging into a single system. One such convergence that is gaining traction is that of Quality Management (QMS) and Environmental Health and Safety (EHS) Systems. This article looks into how convergence can have a powerful effect on an organization, providing a level of visibility that combines two critical areas into a single enterprise system.
GFSI Compliance and the Integrated Management System: Creating a Holistic, Harmonized Solution for the Enterprise
Food Quality Magazine, Feb/March 2012
The GFSI-benchmarked food safety schemes are driving organizations to seek methods of enhancing visibility into their quality and safety operations. This article will describe the challenges faced in a Food Safety Management System without integrated processes, and the best practices needed to integrate an FSMS within the Food and Beverage industry. It will also discuss how integration can extend beyond a company’s four walls, to the supply chain.
GFSI Compliance and Automated Food Safety Systems
Cereal Foods World, July 2011
Technology is playing a major part in compliance with food safety regulations such as the GFSI benchmarked food safety schemes. More and more companies are adapting a consolidated food safety management system to manage these and other processes in one system—this eases the burden on the end user and helps to streamline the process of compliance.
Quality Software & Analysis: Lost in Translation
Quality Magazine, November 2010
Many of today's enterprises are no longer isolated to one corner of the globe—they span continents. With organizations sharing knowledge and information across these global enterprises, it is crucial to effectively translate all aspects of software to ensure harmonized communication. Localization technology makes this possible.
Best Practices of a Pharmaceutical Quality Management System
Regulatory Affairs Journal, Pharma, September 2010
This article describes the best practices for implementing a pharmaceutical QMS as stated by ICH Q10 as well additional aspects of a QMS that can go above and beyond in meeting pharmaceutical quality expectations.
Ensuring Efficient Recall Management
MPO, September 2010
This article will describe why recall management is a necessity for medical device manufacturing firms and how an automated quality management system (QMS) can streamline the recall process by enabling seamless compliance with the best practices of recall management.
Streamline Your CAPA Process: Use Risk Assessment to Improve Quality and Compliance
PFQ, August/September 2010
This article will examine how using a risk assessment model in a QMS can help filter the needles from the haystack by identifying those critical events, mitigating the risk, and preventing recurrence of adverse events.
Change Management and Quality: Ensuring a Change for the Better
Regulatory Affairs Journal, Devices, August 2010
This article explains why quality management should be integrated into the change management process and sets out the different phases involved in doing this successfully.
Successfully Managing Change With Quality Management
Orthopedic Design Technology, July/August 2010
In an industry such as orthopedics, product life cycles are short and change is necessary to keep up with the rapidly increasing pace of the market. Processes of change management are necessary to ensure a successful change in each product, each and every time.
How to Manage a Recall Effectively
Food Quality Magazine, February/March 2010
In the food and beverage industry, brand equity is imperative to an organization’s success. A recall is one of the most devastating things that can happen to any organization within this industry. Added to the cost to consumers and the U.S. Food and Drug Administration (FDA), there are regulatory issues and negative customer reactions to address, as well as the possible effect on market share to consider.
MedWatch Plus: Preparing for Electronic Adverse Events Reporting in the US
Regulatory Affairs Journal, Devices, November 2009
The Food and Drug Administration is taking steps toward mandatory electronic medical device reporting. In this article, we will examine how to best prepare for mandatory implementation and the quality management solutions that are able to assist in the process.
Execute & Verify: Last But Not Least
MPO, September 2009
A quality management system (QMS) picks up where PLM leaves off by comprehensively automating the change management process with the flexibility, collaboration, security, and compliance management necessary to compete effectively.
The Food Safety Revolution
Food Quality, June/July 2009
An automated food safety management system (FSMS) is the best-in-class method for implementing food safety initiatives and for increasing safety and quality in the food chain.
Change for the Better: Change Management and Quality Management
MPO, June 2009
Using change management processes within an enterprise quality management system, quality becomes the foundation of every product or process throughout the product lifecycle.
Integrating Change and Quality Management
MPO, March 2009
In the medical device field, where lifecycles are short and competition is fierce, a change management system that starts at the beginning of the product lifecycle and incorporates quality into each step of the change process is the key to success. Using a quality management system (QMS) to automate the change management process makes this possible.
Change and Quality Management are Necessities for Businesses
MPO, January/February 2009
This is the first installment in a four-part series that will uncover the various phases in companies' change management lifecycles and how a quality management system (QMS) can effectively streamline the elements of change.
A Click Away
MPO, April 2008
Faster, more accurate FDA submissions, tighter quality controls, better productivity and bottom line results - all are just a click away with today's software innovations.
Beyond CAPA: Using Risk Assessment to Streamline Your Quality System
MPO, July 2007
By using concepts such as immediate correction, investigation and risk assessment, your business will be able to focus your quality system on the essential events that have the most impact on your business.
Simplify Your ISO 13485 Trek with Software Automation Tools
MPO, September 2005
By selecting software tools with the flexibility to meet the myriad requirements in the ever-changing world of quality standards, your company will be well along the path to achieving the next milestone of your quality journey.
Key to Software Integration is Flexibility and Familiarity
MPO, January 2005
As software technology evolves, one mantra remains clear - users work best with familiar tools. The challenge for software vendors is to integrate the evolving technology into tools that users are comfortable with.
It All Computes: Software can Ease Workflow, Improve Communications and Speed Products to Market While Reducing Costs
MPO, May 2004
In the race to improve better quality products that reach the market before competitors, medical device companies and their contract manufacturers are adding a new weapon to their arsenal of strategies: software.
Eliminating the Paper Chase: Choose the Best Document Control Software
PFQ, May 2004
The new breed of document control software, in addition to having document control functions, can streamline and simplify corrective and preventive action, change control, audits & surveys, and other processes.