background image for GxP Lifeline
GxP Lifeline

QMS Implementation Tips: How to Get Started

MasterControl’s latest industry brief providing QMS implementation tips for life science manufacturing.

Imagine buying groceries and eating less than one-third of what you purchased. You’d never do such a wasteful thing because you want to maximize the return on your food investments. But that’s exactly the kind of wasted value that’s rampant in the life sciences industry’s quality functions. Among the 85% of companies that have already purchased a quality management system (QMS), only 29% have fully implemented their QMS at all facilities, according to research conducted by MasterControl.

To more closely examine the reasons why the digitization of quality processes is lagging, MasterControl surveyed 152 quality professionals in the life sciences. While most of the respondents recognized the tremendous value a digital quality management system can bring to their organizations, many identified the following issues as the factors preventing wider QMS implementation and expansion:

  • The perception that the cost can’t be justified.
  • Fears that transitioning to a new system and training employees will take too much time and effort.
  • Concerns that new tools or systems will disrupt business.

One of the primary reasons these perceived barriers to QMS implementation exist is because companies across the industry are struggling to fully digitize all their quality processes. Even companies that have already invested in a digital QMS solution have significant issues with manual and paper-based processes, which 32% of respondents to MasterControl’s survey identified as a major pain point.

Although all these QMS implementation obstacles are common and pose legitimate challenges, they can be eased or eliminated altogether with proper planning. So, what do you need to know to start planning your QMS implementation?

How to Implement a Quality Management System

Every journey begins with a single step, as the quote often attributed to Lao Tzu says. When it comes to QMS implementation, that first step entails getting all your people and resources in alignment. It’s a unified group effort, not a decision to be made and carried out by a lone quality manager.

A company would never put one person in charge of deciding which enterprise system to purchase. Big decisions like purchasing a QMS solution come after multiple stakeholders have worked together to make a choice that’s best for the organization. QMS implementation is no different. Any system implemented with the intent of optimizing quality processes and establishing an organizational culture of quality will affect everyone across the enterprise in one way or another. It stands to reason then that key stakeholders from every department touched by the quality management system should be aware of and have input on QMS implementation plans and timelines. When everybody is on the same page and involved from square one, the adoption rate for any enterprise software system that is implemented will be drastically improved.

The process of getting all your people aligned on a QMS implementation plan can be broken down into three essential phases:

  1. Identify and get support of key decision-makers.
  2. Identify other executives and impacted personnel whose support you need.
  3. Set appropriate goals and expectations for time and involvement.

The first two phases are challenging for many organizations because they involve winning over some decision-makers and supporters who may not fully understand how a quality management system affects them and their departments. The best way to influence these potential allies is to explain the benefits that come from deeper digitization and its impact on the bottom line. QMS implementation and adoption goes much more smoothly once decision-makers understand that it’s more economical to adopt a robust integrated solution that connects quality processes such as:

When decision-makers grasp that the alternative is to implement an array of point solutions to manage each process separately (or, even worse, to continue managing them using a hybrid of paper documents and software tools), the decision to implement an integrated QMS becomes a no-brainer.

After buy-in has been achieved, it’s time to focus on determining the resources you’ll need to execute your QMS implementation plan. At this stage, goals are set and a timeline for implementation is established. The personnel who will be most involved in the implementation and use of the new quality management system must be provided with clearly defined expectations. When everyone understands what’s expected of them, user adoption is better. Teams will also be better prepared for any workload adjustments and ready to accommodate the time it will take to get comfortable working with the new system.

Learn the Next Steps to QMS Implementation

Once you’re confident that your people and resources are in alignment, you’re ready to take the next steps to prepare for the implementation of your new quality management system. For a deeper examination of what those next phases entail and to learn all you need to know about how to implement a quality management system, read the “3 Vital Steps to QMS Implementation” industry brief.


James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.

Free Resource
3 Vital Steps to QMS Implementation

Enjoying this blog? Learn More.

3 Vital Steps to QMS Implementation Industry Brief

Download Now
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]