How Technology Can Help Enhance Reliability and Compliance in Life Sciences Manufacturing

In this article, we will explore the impact of technology on life science manufacturing, from intelligent automation to electronic Quality Management Systems.
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Introduction

The life sciences manufacturing industry is constantly evolving, and technology plays a crucial role. By utilizing state-of-the-art technologies, life science manufacturers can achieve higher levels of reliability and compliance than ever before. From intelligent automation to electronic Quality Management Systems, the impact of technology on life science manufacturing is undeniable. In this article, we will explore the role of technology in enhancing reliability and compliance in life science manufacturing.

Benefits of Technology in Life Sciences Manufacturing

With the growing complexity of drug manufacturing and the increasing regulations, the role of technology is becoming crucial to develop reliable and compliant processes. By utilizing innovative technology solutions, life sciences organizations have improved product quality, reliability and compliance with regulations while reducing costs.

The key enabler technologies that allowed these improvements are Automation, real-time monitoring, data analytics, and electronic Quality Management Systems (eQMS).

Automation and Real-Time Monitoring

Automation systems enable precise and repeatable processes and greater traceability. One key benefit of this type of technology is that it can automate and streamline many tasks, reducing errors due to manual processes. Another helpful feature is the ability to automatically track and manage records, providing complete and easy-to-follow audit trails. In addition, technology can eliminate the risk of discrepancies due to transcription errors. This makes it easier to identify trends and areas for improvement.

In particular, one of the most effective ways to improve reliability and compliance is to implement real-time monitoring systems. Through real-time monitoring, manufacturers can track and analyze production data in order to identify deviations from set parameters on the plant floor and address them immediately. This enables manufacturers to address any compliance issue before it becomes more serious.

Life science manufacturing is a highly complex process involving multiple professional teams from different areas. Therefore, providing accurate and timely information between departments is essential to avoid misunderstandings and to take advantage of all the different views inside the company. Automated real-time systems can improve communication between different departments and across different production lines by automatically sharing real-time production data.

Overall, automated systems and real-time monitoring are powerful tools for life sciences manufacturers, offering significant benefits regarding reliability, compliance, and efficiency.

Data Analytics

Data Analytics is a powerful tool that enables manufacturers to dig deeper into their processes and uncover patterns and trends that can be used to improve the system’s reliability.

These techniques allow organizations to analyze large volumes of data quickly and gain valuable insights, allowing them to make more informed decisions. Through data analytics tools, organizations can monitor and measure operations in real-time, track and predict changes in the production environment, and identify potential issues early on. This technology also helps organizations identify improvement areas in the manufacturing process to reduce downtime and increase reliability. By analyzing past data, manufacturers can identify issues causing system failures, such as incorrect settings or equipment operation.

Unplanned equipment breakdowns can significantly impact life science operations, leading to expensive losses in production and supply chain disruption. In response to the risk of experiencing a manufacturing disruption due to insufficient maintenance, some companies may fall into expensive “just in case” over-maintenance. A digital approach to predictive and prescriptive maintenance (PPM) using data analytics can help reduce these losses and improve supply chain resilience. PPM uses algorithms to detect failure patterns across equipment, allowing for earlier failure predictions and more time to plan maintenance proactively. It also provides information on the most significant contributing factors to equipment failure.

These tools can also rapidly detect potential issues in machinery, allowing for proactive maintenance and avoiding further risks to the process.

eQMS

A pharma QMS is a formalized framework of policies and procedures defined to ensure the quality of pharmaceutical products throughout their entire life cycle. The QMS of a life science company must comply with Good Manufacturing Practices guidelines. It typically relies on paper-based records and documents to adhere to documentation requirements. An eQMS uses software to store, organize and manage all documents digitally.

Automated data and document management systems are vital in leveraging digital technology for improved compliance. By streamlining the process of collecting, categorizing, organizing, and storing records and documents, these tools can help organizations to streamline processes, minimize errors and reduce paperwork. Another great benefit of implementing an eQMS is enhanced security for sensitive information. Using an encrypted system ensures that the documents are kept private and secure. This prevents any sensitive documents from being stolen or misused.

An eQMS also eliminates the risks associated with paper documents, such as getting lost, stolen, and physically damaged. Furthermore, electronic records can be securely backed up, ensuring that all critical documents are safe and secure even in the case of an emergency. Centralized document storage also makes collaboration easier, as documents can be shared quickly and easily among multiple users. Automated document management systems can also track employee training status, ensuring that all staff is updated on the latest regulations and protocols. 

With these tools, organizations can more easily monitor, manage, and enforce quality assurance standards.

Final words

With the growing complexity of life science manufacturing and the higher standards set by regulatory agencies, the role of technology is becoming increasingly important in ensuring compliance and maintaining a high-quality production process. 

Automation, real-time monitoring, data analytics, and electronic Quality Management Systems (eQMS) are key enablers allowing life science organizations to improve product quality, reliability, and compliance with regulations while reducing costs. 

By leveraging the power of technology, life science manufacturers can more easily monitor production processes, identify risks, and ensure adherence to regulations. This will ultimately lead to improved product quality.

Even the U.S. Food and Drug Administration (FDA) highlighted the importance of tools that allow continual process monitoring and rapid data analytics in process validation:

“The goal of the third validation stage is continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems for detecting unplanned departures from the process as designed is essential to accomplish this goal..”

Automation systems offer a significant advantage in terms of process accuracy and repeatability. Automating tasks reduces the chances of errors caused by manual labor while also providing a comprehensive audit trail. In addition, it eliminates the potential for discrepancies due to transcription mistakes, making it easier to identify trends and areas for improvement.

Manufacturers can use real-time monitoring to closely oversee production data, allowing them to detect discrepancies from established standards and address them before they cause major problems or compliance issues. Data analytics can also be leveraged to predict machinery failure and improve maintenance planning. For example, algorithms like Machine Learning can recognize breakdown patterns in equipment and make accurate predictions of when a failure may happen, giving extra time to plan maintenance. 

eQMS can be an invaluable tool for life science companies to ensure compliance with GMP guidelines. It eliminates risks associated with paper documents, offers enhanced security for sensitive information, minimizes errors, and facilitates collaboration among multiple users. In addition, automated tracking of employee training status helps to ensure everyone is up-to-date with the current GMP. Therefore, implementing an eQMS could be an excellent way for life science companies to improve their compliance and quality standards.

Technology has become a critical component of life science manufacturing, and organizations must be up-to-date with the latest technologies in order to remain competitive. By utilizing innovative technologies, life science manufacturers can stay ahead of the curve and ensure that their products meet the highest standards of reliability and compliance. The benefits of technology in life science manufacturing are clear, and there is no doubt that it will continue to be an important factor in the evolution of the life sciences industry.

If you want to learn more about technology’s crucial role in enhancing reliability and compliance in life science manufacturing, join our upcoming webinar with Reliability Expert Dave Porrill!

In this webinar, you will discover the critical factors for success, including 🔑 leadership support, accurate data, preventive/predictive maintenance plans, planning & scheduling work, and maintenance-integrated production cycles.

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Qualistery

Qualistery

Qualistery is a state of the art GMP training institution and a home for pharma professionals, where they can share their expertise with the rest of the world.

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