It is well known that Quality Management Systems (QMS) are essential for any industry, but what are they and how can they be applied to the life sciences sector? For businesses working in the life sciences and pharmaceutical sectors, a QMS is essential for the entire product life cycle, from the purchasing of raw materials to the deployment of manufactured products and services. QMS helps ensure that life sciences companies comply with global regulatory requirements and standards such as Good Manufacturing Practice (GMP).
What is meant by quality management system for life sciences?
Quality Management Systems (QMS) are designed to guide the delivery of quality products in a timely manner. A life sciences QMS can drastically improve the operational efficiency of pharma, biotech, and other life sciences organizations.
What is the purpose of quality management?
The implementation of a QMS system has two main goals:
- To create continuous improvements via efficient quality management processes;
- To satisfy the regulatory standards set by different administrative agencies.
Why is quality important in science?
Quality control processes monitor and maintain operational standards. To certify product quality, life sciences companies must detect, reduce, and correct any problems found along the supply chain.
Producing precise and accurate results
The purpose of medicines and medical devices is to help people and save lives. Therefore, it is extremely important for life sciences solutions to be as efficient as possible. Through quality management, standard operating procedures are carefully monitored to guarantee everything is going according to plan.
For example, quality control in a lab setting certifies the integrity of samples. Without proper monitoring procedures, samples could become compromised. This could lead to a wide range of potential risks, from skewed test results to considerable losses of time and money.
Strengthening customer relationships
By keeping good product quality standards, life sciences companies can better meet expectations, avoid complaints, and develop customer trust. In the life sciences industry, a mistake can be a matter of life and death. If a company loses customer trust, it will most probably never get it back. Adhering to life science quality management processes leads to consistent product quality, thus keeping products safe and appealing to customers.
Maintaining a safety standard
Compliance in life sciences goes beyond meeting regulatory requirements and quality standards. It also ensures the safety and well-being of everyone working towards the creation of new products.
Subpar quality control standards endanger personnel. For instance, a lack of a solid CAPA strategy can cause minor accidents to quickly grow into major issues. Quality control keeps equipment from malfunctioning and trains employees to follow proper and safe procedures. It also ensures the good standing of raw materials and products and sets guidelines on how hazardous materials are to be disposed of.
Who is responsible for using quality management systems in life sciences?
Usually, a project manager or quality manager is responsible for pharmaceutical quality management systems. However, all team members should play a role in the improvement of quality management processes.
What are the 5 elements of QMS in life sciences?
1. Document management
Document management systems are an integral part of every QMS. Not only are they essential to regulatory compliance, but they also complement the overall quality culture of an organization. A major advantage of the adoption of an electronic quality management system is the capacity to handle document control processes digitally. Traditional, paper-based quality processes can be substantially improved by software solutions, allowing for extra features such as automatic data gathering and analysis.
Life sciences manufacturers should expect their document management strategy to achieve the following:
- Allow the drafting, review, and approval of documentation
- Enable collaboration through specialized tools
- Leverage cloud-based solutions
- Automate processes and streamline document approvals
- Simplify audit management through role-based access and clear audit trails
- Meet the regulatory requirements set by the FDA CFR Part 11
Benefits of electronic document management in Pharma
2. Training management
Life sciences companies are required to be compliant with certain training requirements. A highly trained workforce can participate in the safe enactment of quality policies while also improving the performance of core quality processes.
A life sciences QMS must be able to address the training requirements of personnel across different departments, such as HR, leadership, product development, and manufacturing. A company’s training management capabilities should be an accurate portrayal of its quality standards. Training activities should be streamlined and leadership should have visibility to track training progress.
3. Quality event management
The life sciences industry requires extensive risk management. Potential issues with products and processes abound. Whenever these issues, known as quality events, are encountered, they must be assessed and dealt with in an organized manner.
Any activity or process that may impact performance must be controlled, monitored, and verified. All aspects of quality events, including the decisions made to address them, must be properly documented. Potential quality events include CAPA deviations, customer complaints, non-conformances, and logistics mistakes. Demonstrating consistency and control whenever issues occur is indispensable to achieving true quality.
4. Product development
Product safety and quality are particularly important in the life sciences industry. In the world of R&D, regulatory compliance processes must be handled for years before a product is brought to market. Therefore, staying compliant with product development documentation is of utmost importance.
Failure to meet quality regulatory standards can lead to issues gaining market approval, bloated costs, etc. A QMS for life sciences can simplify compliance with industry requirements for product development documentation. Therefore, its adoption during the early stages of R&D is advantageous.
5. Closed-loop quality management
Interconnecting processes and information is essential to capture all non-conformances. Having a centralized location to monitor, review, and investigate issues guarantees these can be promptly solved in the most time and resource-effective manner.
The best QMS software platforms can connect quality processes and performance data to improve an organization’s overall operational efficiency. Through superior data quality and visibility, a digital quality management system can empower a life sciences company to respond to quality events and other risks in real-time.
Key elements of pharmaceutical quality management systems
How do you implement a quality management system in life sciences?
Carry out an internal QMS audit
To begin with, one should assess their current system’s capabilities. A thorough analysis of quality management processes, from document management to concrete assignments, should be carried out. The purpose of this audit is to gauge the current quality system’s strengths and weaknesses. It can also help determine how far a company is from fulfilling compliance requirements such as ISO compliance standards. Internal QMS audit results can be used to develop measures that optimize process speed and profitability.
Get decision-makers onboard
For a QMS to work as intended, it must be supported by management and deployed throughout every department. To make sure quality management implementation is achieved and no corners are cut, key decision-makers should be willing to make it happen.
Quality managers and team members are responsible for selling the plan to the board, the IT manager, C-level executives, and other professionals involved in the project. Stakeholders should understand the advantages of QMS as well as all the issues and operational bottlenecks it is able to address.
Establish a quality policy
The best way to communicate what a QMS is trying to achieve is through a clearly defined quality policy. Specific and concrete objectives should be articulated to help everyone understand the why and how of the current policy changes.
Potential objectives include:
- Optimizing operational efficiency
- Ensuring regulatory compliance
- Improving customer satisfaction
- Increasing market access, responsiveness, and/or competitiveness
- Reducing risks
- Attaining better data visibility
- Enhancing the organizational culture of quality
- Creating more cost-effective processes
Assemble a specialized QMS task force
After the establishment of quality goals, one should gather a team to bring QMS implementation to fruition. Oftentimes, the project head of a QMS implementation belongs to the quality or IT departments. However, staff from every department impacted by the project’s goals should participate to ensure broad-scale acceptance of changes.
Implement QMS software
QMS software functionality can lead to improved productivity, especially when its different parts are integrated and working in tandem. Additionally, cloud-based QMS solutions are always kept up-to-date, making sure the systems are always compliant with changes in regulation.
A digital QMS solution can reduce the time it takes to access and share documents. Through a well-implemented QMS, one can view non-conformance issues and launch CAPA strategies on short notice, while also requesting the appropriate updates to document management, staff training, and more.
Quality management system software for life sciences
The best QMS software platform should be able to meet your current and future quality needs. Agatha Clinical QMS represents the latest in enterprise quality management for life sciences, designed specifically to manage clinical compliance and quality processes.
From the moment it is initially deployed, the Agatha QMS solution is ready to capture deviations, document CAPA procedures, and manage change control processes. Thanks to Agatha Clinical QMS, life sciences organizations can accelerate trials, improve the results of clinical studies, and address failures in the most efficient manner.