Effective Quality Management Systems

Effective Quality Management Systems Are in Demand

In today’s dynamic global market, enterprise quality management system (QMS) solutions are becoming commonplace. In fact, a recent AMR Research survey on the top software components for companies shows that effective quality management system solutions are number one on the list. What’s prompting the increased demand? No doubt it’s the mounting pressure from the FDA, EMA, ISO, and other global regulatory agencies. If your organization has yet to implement an effective QMS to meet its complex compliance challenges, you are missing out on a host of competitive advantages.

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Effective Quality Management Systems: Build vs. Buy

The advantages of automating your quality processes into an effective quality management system are compelling. Any company that wants to stay competitive and compliant needs an automated effective quality management system. But should you build your own homegrown system or buy a proven, validated QMS? Building a homegrown QMS has its advantages, but it also presents unique challenges and raises important questions: Will you build it yourself or work with a consultant? Who will write the software? Will it be reliable? Will it fulfill regulatory requirements? Will it scale? Will routine maintenance consume too much precious IT staff time? Ultimately, will it work? It’s not unheard of for companies to start building an effective QMS only to end up buying a system anyway, resulting in an enormous waste of financial and human resources.

Over the years, we’ve helped hundreds of companies who’ve struggled with the “build vs. buy” dilemma, so we understand the unique challenges regulated companies face. Based on the lessons we’ve learned, we’ve developed MasterControl to be configurable, off-the-shelf, end-to-end effective quality management system designed to significantly improve efficiency, accelerate compliance, and reduce cost by helping users save time and effort. With MasterControl, you can start reaching your compliance goals almost immediately

Digital Quality Management Resources

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Solution Overview: MasterControl Quality Excellence
White Paper: 6 Must-Haves for a Quality Management System (QMS) White Paper: Getting Executive Backing for a Digital QMS
Research Report: The State of Digital Quality Maturity in Pharma and Medtech

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Competitive Advantages of Effective Quality Management Systems

It’s no secret that regulated companies that fail to embed an automated, effective QMS solution into their manufacturing and value chain operations expose their brands to increased compliance risks, and thus weaken their competitive standings in the market. But automating your quality processes, such as document control, training, corrective action, and risk management, into one easy-to-use, easy-to-access effective quality management system can give your regulated organization the competitive edge it needs to achieve compliance success, and win the race to market.

Here are a few of the advantages you can expect to gain by implementing an automated, effective QMS:

You’ll save time—and lots of it:

Manual or paper-based quality management systems are time-consuming, inefficient, and error-prone, and these issues are compounded when your teams or suppliers are geographically dispersed. Automating your quality processes into one holistic, effective quality management system will not only enhance visibility and collaboration, but also allow you to stop chasing paper, and devote more time to running your business.
You’ll improve profitability—and ROI:

Let’s face it—when you save time, you save money. Whether you save that money by avoiding costly product recalls or cutting your corrective action cycle time in half, you’ve already seen a return on your QMS investment.
You’ll accelerate compliance:

Saving time and money is great, but, for regulated companies, it all comes down to regulatory compliance—and the risk of non-compliance has never been higher. Using MasterControl’s effective QMS to manage your quality process enables you to minimize costly and embarrassing product shortages and/or recalls. This is because effective quality management systems like MasterControl are specifically designed to drastically reduce these risks by controlling the quality and integrity of your quality management processes, which, in turn, helps you ensure compliance with the FDA and other global regulatory agencies.
You’ll deliver safer, higher quality products to your customers:

Gaining a competitive advantage is only part of the appeal of an effective QMS. Managers in best-of-breed life science companies are realizing that effective quality management systems also support the next generation of quality management, which views improving product safety and efficacy as important as satisfying regulatory requirements. MasterControl’s QMS help you reduce costs, increase efficiency, and reduce risk within your organization while helping you to achieve and maintain your required regulatory agenda. These benefits, which all effective quality management systems should provide, result in the production and delivery of higher quality products.

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How MasterControl’s Effective Quality Management System Differs from Other Systems

MasterControl is a leading provider of effective quality management systems to regulated companies worldwide. Unlike other effective QMS solutions, MasterControl been designed to integrate with other enterprise systems quickly and easily. Furthermore, MasterControl allows you to create a unified method for streamlining and managing all of your critical quality processes such as document control, risk management, audit, training control, quality event management (complaints, MDR, NCMR, CAPA, deviations, nonconformances), as well as BOM management, project management, and change control (ECR,ECO). Few other effective quality management systems offer such one-stop-shopping.

One of the biggest advantages of using MasterControl is that the system allows you to start with a point solution that can be easily developed into a full-fledged, fully integrated effective QMS later on. Integrating quality processes under a single enterprise platform makes the QMS more transparent to management, users, auditors, and regulatory inspectors. Documents and processes are easier to review and maintain. Compliance requirements are less likely to fall through the cracks.

MasterControl is also web-based, so users can access the system from virtually anywhere in the world, at any time. Users can also access the system using a tablet or a smartphone. This capability is a distinct advantage over other less effective quality management systems. Mobile access is particularly useful to field employees or those who often travel or work off-site. Those users will be able to participate in quality processes even when they are not in front of their computers in the office, increasing efficiency and productivity across the entire enterprise.

To learn more about MasterControl’s effective QMS, contact a MasterControl representative.

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Effective Quality Management Systems