Building Your Quality Management System From the Ground Up

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Building Your Quality Management System From the Ground Up

Your success as a pharmaceutical company heavily relies on the implementation of a quality management system. With ever-changing FDA regulations and technological advancements, the demand for solid infrastructure with quality in mind is increasing. Truthfully, the success of your quality management system is critical for the integrity of your company and the quality and purity of your pharmaceutical products, as it directly impacts your patient’s safety.

What is a Quality Management System?

A Quality Management System (QMS) is the practices and procedures set in place by a company to ensure quality and products that adhere to the compliance and regulatory requirements of the FDA and other regulatory bodies. A QMS is essential for continual growth, improvements, and producing a safe and effective product.

Innovative pharmaceutical companies who choose strategically to get ahead of the game by starting with quality vs. simply maintaining for regulatory compliance will significantly benefit in the end. A successful QMS will allow you to improve product quality, minimize risk and meet the needs of your customers. Ultimately, you will be able to deliver high-quality products to customers around the world in an efficient and safe manner.

Building a solid QMS from the ground up can be challenging, but if done correctly, your business will excel and reach new heights ensuring patient safety and regulatory requirements are met. So, how do you build the framework for an effective quality management system? Here are five essential elements to keep in mind when developing your QMS that meet and exceed ISO standards.

Processes and Procedures

Organization for a highly regulated industry will require structured processes and procedures in place. When planned operations are executed, you eliminate uncertainty and ensure internal efficiency for a high-quality outcome. A process-oriented approach helps streamline all stages of a product lifecycle and is an essential component of your QMS.

Pharmaceutical quality management systems with a focused process optimize performance and produce consistent results. Not to mention the transparency achieved for the entire organization during the product lifecycle is another essential component to your success.

By implementing a highly advanced QMS, your business can ensure your quality management processes meet ISO and FDA requirements.

Benefits of innovative process:

  • Transparency throughout the product lifecycle
  • Elimination of product deficiencies
  • Cohesive structure in the organization
  • Enhances opportunities for growth

Leveraging Analytics

Data equals knowledge. Evidence-based decision-making is a critical element of ISO and will drive the success of your organization, improving quality and satisfying customer needs. Closely monitoring statistics to adapt to the ever-changing customer demands will help you continuously improve your products and services.

Insights into trends and real-time feedback help you make an informed decision to propel your company forward in a competitive market. Access to accurate QMS data, market research, reviews, audits, records, and employee feedback are just a few of the advantages of leveraging analytics and incorporating smart systems.

Keep in mind partnering with a reputable healthcare QMS consultant is vital to ensure you are utilizing the latest technology in QMS software. The key to implementing a successful QMS is to find experienced consultants in the pharmaceutical space who are familiar with ICH Q10 and ISO guidelines which are manuscript guides that display best practices for an efficient quality management system. Both models provide a structured format for practical business support and clarification throughout the product lifecycle.

Customer Forward Thinking

Do you know what your promise is to your customer? If you don’t, it is vital to get down to the basics of what it is your customer is expecting of your products and services. It is imperative to have a consistent and clear promise that is well-understood throughout your entire organization. The ultimate goal is to achieve customer satisfaction and ensure product safety. 

Once you have identified your promise to your customers, what do you do to ensure you always deliver this promise? What processes take place to make sure your customer is always taken care of? Honing in on these types of questions in the beginning stages of your QMS will pave the way for a brighter future within your company and significantly reduce the risk of product defects and service failures.

Remembering that you are changing lives should be your ultimate driving force for delivering high-quality products. Your consistent actions equate to building trust, value, and continued customer loyalty.

It Starts with Leadership

A successful company is defined by its leadership. If your leadership is lacking, so will the rest of your organization. Those who strive to provide better-than-average results start with a strategic framework for scalability that begins at the top.

It is integral for senior management to strongly support the quality management system in order to create successful products and services that improve the lives of customers. Leadership should share a common goal to generate unison across the organization by leading by example and implementing the following responsibilities.

  • Commitment 
  • Communication
  • Quality resource management
  • In-depth planning and procedures
  • Seek opportunities for improvements

In a highly regulated industry such as pharma, your company cannot afford to have leaders who are not aligned with your vision. This will ultimately lead to product errors and failed compliance.

Employee Engagement and Culture

Quality products and services start internally. Often overlooked, this is a vital step in your quality management system. Quality should be engrained in your culture and not something you add in later. 

An excellent starting point is to make sure your employees understand what quality means to your organization and how you define it. What is your commitment to quality products and services, and how will you achieve this?

Every single employee should value and understand the importance of a cohesive culture where everyone is in alignment with the same mission and goals. Without solid employee engagement and culture, you risk the ripple effect it may have on your products and services.

Studies have shown that statistically significant improvements in the overall performance of pharmaceutical QMS revolve around the involvement of employees and a strong culture within an organization.

Improving employee engagement starts with adequate training, accreditation, communication, rewards, and recognition.


QRCare is a quality and regulatory consultancy service that provides organizations with the support needed to develop and maintain strategic quality and regulatory efforts. Whether they are establishing a system from the ground up, preparing for a supply chain inspection, or implementing change control, QRCare offers assistance to customers throughout their quality and regulatory journeys. For more information about partnering with QRCare, please visit here.

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