Good manufacturing practices are the underpinning of every life sciences business. At the heart of the organization, ensuring end user safety is everyone’s goal. In many organizations, the quality management system (QMS), learning management system (LMS), and manufacturing execution system (MES) work together in service of this goal. This blog describes the essential functions of these systems, why they should be validated, and how they can be configured to ensure seamless data flow across your life sciences organization.
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A QMS is a set of processes and procedures for quality planning, quality control, and quality improvement. An organization implements a QMS to ensure that its outputs (products or services) consistently meet or exceed customer and regulatory requirements. The QMS provides a framework for managing and continually improving quality in all aspects of the organization, including design, development, production, delivery, and customer service. A software-based QMS establishes and maintains a culture of quality throughout the organization and provides a systematic approach to identifying and correcting problems and reducing waste.
An LMS is a software platform used in the pharmaceutical and biotechnology industries to manage, deliver, track, and report on training and learning activities. It serves as a central hub for organizing and administering various courses, modules, and training materials. In the life sciences, an LMS is crucial for ensuring compliance with regulatory requirements, such as current Good Manufacturing Practices (cGMP) and current Good Clinical Practices (cGCP).
An MES monitors and controls processes on the production floor. It collects real-time data from various sources, such as machines, sensors, operators, and other information systems, and provides accurate and up-to-date information about the status of production activities. It enables organizations to optimize resource allocation, assure quality, manage inventory, provide traceability, and document compliance. An MES also leads to data-driven decision-making and continuous process improvement.
The LMS can be interfaced with the QMS and the MES, where the relevant quality documents and procedures are stored. In addition, each of these systems is capable of interfacing with a laboratory information management system (LIMS) or an enterprise resource planning (ERP) tool, to give organizations a holistic view of their data. Such interconnections and improved data flows enable wise business decisions. However, in regulated life sciences organizations, these systems require validation.
Validating the QMS ensures product quality and end-user safety in the life sciences industry. Various functions of the QMS that contribute to the organization’s culture of quality and safety include document and change controls, corrective and preventive action tracking, risk management, pharmacovigilance, and internal or supplier auditing.
QMS validation tests that the essential quality control (QC) functions are working as intended and that the system is fit for purpose. The importance of QC in the life sciences industries cannot be overstated. There are many instances of food-borne diseases or contaminated eye drops or asbestos in makeup to keep QC personnel up at night. A validated quality management system maintains consistent quality throughout the manufacturing process by tracking deviations and maintaining all document versions.
Adding validation to your QMS maintenance schedule ensures that all applicable regulatory requirements can be more easily tracked and met with confidence. The current U.S. Food and Drug Administration (FDA) guidance for pharmaceutical quality systems follows the International Conference on Harmonisation Q10 guideline. Validating a quality management system helps companies meet these requirements, adopt a quality by design (QbD) framework, and avoid compliance issues.
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Some life sciences business managers may be unaware that the organization’s LMS must also be compliant with U.S. Code of Federal Regulations 21 (21 CFR) Part 11. A compliant LMS includes electronic signature capture, audit trails, version control for courses, and robust reporting capabilities. A validated LMS streamlines employee training and ensures that an organization’s staff members are well-informed and qualified to work in highly regulated environments. The FDA itself uses LMS technology to provide training on regulatory processes, submissions, and compliance for industry professionals.
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Validation of the MES is crucial for operational efficiency and product integrity in the life sciences industry. The FDA draft guidance for data integrity and compliance with drug cGMP stresses the importance of validating the MES to ensure consistency in product manufacturing. It is often difficult to ensure consistent processes from batch to batch in life sciences manufacturing; a validated MES will monitor the critical batch production parameters. Additionally, the MES can alert the appropriate personnel to issues that require intervention and reduce the likelihood of human errors.
The MES fulfills another crucial function in life sciences manufacturing, by ensuring traceability. Knowing where the raw materials in a product have come from, and where the finished product is going, makes recalls easier to manage and minimizes risks to the end user. Validation of the MES provides assurance that all functions of the MES are compliant with cGMP and will stand up to a regulatory audit.
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Modern enterprise systems are a key component of Industry 4.0, or the fourth industrial revolution. Industry 4.0 involves the integration of digital technologies, such as the internet of things (IoT), artificial intelligence, cloud computing, and big data analytics, into life sciences industries. Validating these modern systems enables life sciences manufacturers to create smart production environments that are more agile, efficient, and responsive to customer needs.
The evolving regulatory landscape in the life sciences industry will require the flexibility to navigate complexities and adapt to changing standards (CSA, anyone? ). When your organization is focused on science and consumed with everyday business needs, it can be difficult to build the expertise internally to manage a QMS, LMS, or MES validation. We hope this blog post has convinced you of the wisdom in ensuring your enterprise systems are validated as often as necessary to maintain the compliance of your systems. Hiring a qualified third-party consultant can be a wise investment when your internal team has neither the time nor the expertise to see it through.
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