Quality

Quality Digital Maturity Model

What is a digital maturity model and how does it affect quality management?

It really comes down to developing a digital adoption strategy that supports true quality maturity. Quality management maturity (QMM) is an initiative being pushed by the U.S. Food and Drug Administration (FDA) aimed at reducing supply and value chain disruptions in the pharmaceutical industry. These disruptions have far-reaching socioeconomic impacts that go well beyond delays in getting products to market. Read more about how quality organizations can use a digital maturity model to achieve digital maturity in order secure the supply chain and their own place in it.

Free Resources

The State of Digital Quality Maturity in Pharma and Medtech

Frequently Asked Questions About Quality Digital Maturity Model

What are the key components of a quality digital maturity model?

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A quality digital maturity model is simply a progressive representation that clearly differentiates between digital maturity levels. It should include both technological features and quality objectives. It may be embedded with value-driven objectives. Finally, it should also include you.

What are the benefits of using a digital maturity model for quality improvement?

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A quality digital maturity model quickly shows you exactly where you are in your digital transformation journey. You can use it to evaluate your progress towards digital maturity and simultaneously your progress toward QMM. Without this big picture it is difficult to even start the process of digital transformation, let alone finish it.

What regulations require a digital maturity model?

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There are no current regulations requiring digital maturity or even digital quality management, however the FDA states that mature quality practices will require the use of advanced technology. Consequently, organizations that undergo digital transformation in quality management will rank higher on a QMM rating system .

How can a company use a digital maturity model to benchmark performance against industry standards?

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A relevant digital maturity model must account for the main tenets of Industry 4.0, namely digitization, automation, and integration. You can map optimal quality management practices, regulations, and standards you are striving to fulfill to these technologies. Once you add your competitors’ capabilities to the mix, you can evaluate your own digital performance against all three dimensions.

Free Resources on Quality Digital Maturity Model

Select all the digital transformation resources you’re interested in downloading.

Case Study: Fagron Case Study
White Paper: 6 Must-Haves for a Quality Management System (QMS)
Solution Overview: MasterControl Quality Excellence
Ultimate Guide: The Ultimate Guide to Pharmaceutical Quality Management
Research Report: The State of Digital Quality Maturity in Pharma and Medtech

Achieving Quality Digital Maturity

The life sciences lag behind other industries in their degree of digital transformation. Consider these practical steps to achieve full quality digital maturity.

Start with a digital maturity model and a plan.

Before you can invest any real time and money into your digital transformation, you need to pinpoint where you are with your current digital quality management capabilities and where you need to be. Comparing yourself against a digital maturity model will do two things for you.
First, it will outline for you digitization trends in quality management and highlight particular features and capabilities that are essential to adopt to keep pace with them.
Second, it will provide a general roadmap you can follow to move from less to more mature digital quality management practices and tools.
Align your stakeholders and get executive buy-in.

The efficiencies and value of digital quality management are generally understood. However, because digital transformation in quality management requires a custom strategy, change, and resources, you must demonstrate value with evidence.
Isolate metrics that reveal how long your processes take and how many errors are occurring. Contrast those against the efficiencies a digital QMS solution can offer, such as increased innovation and production in less time with fewer resources.
Assign primary stakeholders that will be most impacted by changes to help gather this evidence. This allows them to articulate their current pain points and positively anticipate a digital solution very early in the process.
Take a modular approach to digital transformation in quality management.

Digitization is the first step in any digital transformation – but that doesn’t mean you have to digitize everything all at once. Evaluate your current QMS to identify areas of highest risk and highest value. Be strategic and clear in your digital transformation priorities.
For example, you may need to begin by digitizing your documents as they form the basis of any compliant quality system. Then you may look at how well you manage training requirements. Ask yourself whether you need to get a handle on quality event management (QEM) to preserve your corrective action/preventive action (CAPA) system. Do you need to automate change control, risk management, and so forth?
Choose a configurable electronic quality management system (eQMS).

Digital quality management solutions are comprised of purpose-built software that helps you streamline and automate essential quality tasks. An eQMS is an example of this. Partnering with a proven digital solution provider allows you to implement a solution without having to develop code from scratch.
The advantage of implementing a configurable eQMS is that you can set up the solution to match your existing processes rather than modify your processes to match the software. This helps to break down barriers that can make digital adoption difficult. Adoption rates in turn ultimately determine how successful your digital transformation is.
Complete your digital transformation with an enterprise solution.

Regardless of the barriers you encounter along the way – you will complete the journey of digital transformation in quality management if you choose to implement an enterprise quality management solution. There’s no going back, right? By definition, enterprise QMS solutions allow you to connect quality management processes and data across your entire organization and are a complete solution.
Carefully choose a trusted enterprise provider that can demonstrate results and guarantee outcomes. Reputable providers have a stake in your success, are poised to support implementation, and can offer the added value of ongoing innovation to their products and consequently add more value to yours.