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Pharma QMS: The Key Elements of QMS in Pharmaceuticals​

Ensuring Quality and Compliance Across Your Organization

Did you know that a pharmaceutical company can receive misdemeanor fines that go up to 500,000 dollars and criminal fines that go up much higher, for FDA violations? In addition, they could also face delayed product launches and reputational risks that can pose further financial disadvantages.

Pharmaceutical companies must implement solutions that ensure quality and compliance. Are you looking to take your pharmaceutical operations to a whole new level? Are you thinking about adopting an industry-standard pharma QMS?

In this article, we will be going over the critical elements of QMS in the pharmaceutical industry. That way, you can take your company to the next level regarding quality, reliability, consistency, and sustainability.

Keep reading to learn about the key elements and more of a pharmaceutical quality management system.

What Is a Pharmaceutical Quality Management System?

There are many critical stages in the drug manufacturing process. But how do you ensure quality procedures at each stage? You need a pharmaceutical QMS.

A pharma QMS helps develop and ensure quality procedures in the different product life cycle stages. This allows manufacturers to meet regulatory and customer requirements.

There are several reasons why a QMS solution is essential for pharmaceutical companies:

  • Reduce the Risk of Errors- Not having a pharma QMS solution means that there are more chances for errors. In the pharmaceutical world, errors can quickly become costly and even worse, risk safety. A QMS system can help facilitate communication between your employees. This helps your employees understand their roles and responsibilities. By ensuring everyone is aware of their responsibilities, the risk of errors can be reduced.
  • Reduce Costs- Because a pharma QMS can help reduce errors, costs associated with those errors will be reduced. When errors occur, money is not only lost on products that don’t meet standards, but time is also lost by requiring additional employee time to redo the work, slowing down the overall process.
  • Make Quality a Culture- You want your company to be associated with quality. A QMS serves many functions which will help build a quality and safety-first culture.

Key Elements of Pharma QMS

There are various key elements to focus on when choosing a quality management system. Each of these elements will help to ensure the process is smooth from beginning to end.


Leadership plays a significant role when it comes to a strategic and systemic approach to quality-driven performance. They hold the responsibility of defining and refining the vision, sharing its purpose, and encouraging employee engagement with quality goals.

Your company’s culture of quality starts with your leadership. The culture should also allow for transparency, improved communication, and provide easy access to information.

Your QMS should support the leadership vision and goals through the following activities:

  • Support for communication and real-time collaboration
  • Training and education to help all employees improve quality
  • Coordination of processes throughout the company.

Employee Involvement

The responsibility of quality falls heavily on leadership’s shoulders; however, every person involved in developing and manufacturing pharmaceuticals has a responsibility. When every person owns their responsibilities, a culture of quality can truly be realized.

One study looked at eight components of an ISO 9001 QMS. The purpose was to find out which principle had the most significant impact on quality.

Components included:

  • Evidence-based decision making
  • Mutually beneficial supplier relationships
  • Customer focus
  • Leadership
  • Employee involvement
  • Process approach
  • Continual improvement
  • Systemic management


The study was completed using interviews and statistical analysis. Researchers looked at 40 large European pharmaceutical companies.

It was determined that employee involvement through training, communication, empowerment, recognition, and rewards have a positive effect on the quality results.

Process Centered Approach

The next key element of the QMS is a process-centered approach. If the goal is continuous improvement, efficient performance, and predictable results, the workflow should be approached from this perspective.

Tasks completed should not be treated as individual and unrelated tasks. Instead, the tasks should be looked at as interrelated.

This means clear SOPs for every task and responsibility are needed. This strategy looks at the entire product lifecycle, which is good because of updates to the cGMP that require assuring quality standards through the product lifecycle.

If your company relies on outsourced manufacturing partnerships, a process centered QMS is even more important.

Integrated Systems

Products and performance cannot be optimizedur if your systems are not properly integrated. That is one of the many reasons why transparency is essential when it comes to the product lifecycle.

The QMS system will have a framework that will govern interrelated processes, so a system that complies with cGMP and ICQ10 and can support transparency is needed.

Many elements are critical for integrated QMS for pharma. Researchers have looked at this more in-depth and determined that integrated systems need to support:

  • Personnel
  • Quality policy
  • Production
  • Development and implementation
  • Facilities and equipment
  • Documents
  • Management responsibilities
  • Risk analysis
  • Supplier production and analysis
  • Self-inspection
  • Evaluation of purchasing and suppliers
  • Measurement, analysis, and improvement
  • CAPA
  • Complaints and recalls
  • Monitoring and control

It is also important for your QMS software to be intuitive, efficient, and scalable.


If you are not continuously improving, the road ahead is rough. There is a lot of pressure to meet regulatory requirements, pricing pressures, and client expectations.

You can continue growing and improving by creating better internal efficiencies, meeting current and future customer expectations, and adapting to new regulations. Your QMS software should assist you with providing these business outcomes.

This can be done in a variety of ways. For example, it can provide data and report on completed training that ensures competency. It could also provide a centralized repository for analyzing data used to develop objectives for improvement.

Evidence-Based Decision Making

One of the core principles of ISO is evidence-based decision-making. This shouldn’t be surprising because it is more likely to get expected results when decisions are made that are based on data.

However, evidence-based decision-making goes deeper than that. The ICH Q10 has an apparent focus on companies shifting to risk-based management methods based on real-time data insights.

This means executives need to make decisions based on data throughout the product lifecycle. The QMS should be expected to provide analysis capabilities and a complete picture.

The data will help leadership determine where and when changes are neededin order to protect product quality. Because data is so essential, the QMS needs to allow data from various sources to provide transparency for the team.


Communication is essential on many levels for a pharmaceutical company’s success. Systems should include capabilities for the productive and efficient exchange of information between leadership, quality, employees, and third-party organizations in the supply chain.

It is recommended by the International Organization for Standardization that companies pool and share information, resources, and expertise with relevant interested parties. This will help support relationships in a quality-driven company.

QMS software doesn’t have to support collaboration; however, it can help with communication if you have a QMS that does. Cloud-based software can help with real-time collaboration. Your system also needs to make communication easy to track and allow for communication with stakeholders about product quality and status.

Choose a Pharma QMS That Supports Your Company's Goals

As a pharmaceutical company, you know a lot goes into creating a quality product that meets regulatory requirements. Choosing the right pharma QMS can help make your job easier.

However, before you select your QMS you need to make sure it has the correct elements. Are you ready to find out more about our pharmaceutical QMS? Book a demo today to find out how we can help you create a culture of quality. Achieve operational excellence with our proven solutions and best practices to drive improvement across quality and regulatory operations.


Ready to learn more? Talk to our QMS experts!