The life science industry requires robust quality systems to ensure product and regulatory compliance across all related functions. The FDA guidance for an effective quality management system for a pharmaceutical manufacturer, the ICH Q10 model, is based on ISO quality concepts, including GMP regulations and ICH Q8 (Pharmaceutical Development) and ICH Q9 (Quality Risk Management). The FDA guidance suggests that the quality system should enhance the following elements at all levels of the product lifecycle:
• Process performance and product quality monitoring system
• Corrective Action and Preventative Action (CAPA) system
• Change management system
• Management review of process performance and product quality
This is the minimum list of quality system elements for any pharmaceutical manufacturer. Therefore, an organization must select a quality system with applications to meet these functionalities as well as any other requirements specific to their product lifecycles. In addition, pharmaceutical companies need to implement a quality system that will align with their business practices, processes and products.
However, companies are often uncertain about whether to implement a quality management system (QMS) or the quality management modules (QM) of their existing enterprise resource planning (ERP/QM) system. Furthermore, since these systems generally have overlapping functionality, for those companies that have already implemented both systems, there may be debates about which system best addresses a given functional requirement.
Although both QMS and ERP/QM address various elements of quality and compliance, they come from different market directions and offer overlapping but different functionalities. In general, QMS focuses on automating quality processes across the enterprise (not just the quality department), while ERP/QM are more focused on quality transactions and data within supply chain and manufacturing processes. Let’s look at each of these systems in more detail.
QMS for the pharmaceutical industry is designed to automate, centralize and consolidate incident tracking, workflow management and regulatory reporting for all quality processes and practices. This software focuses on providing automated quality functionalities across the enterprise to areas from research and development to regulatory, manufacturing, IT and facilities. Quality assurance, regulatory affairs and clinical operations are specific functions that need to adhere to stringent quality and compliance standards. For quality assurance, QMS enables a company to centralize and integrate key quality processes, such as:
• Management and reporting of deviations
• Complaint handling
• Supplier quality, internal/external audits
• Change control
• GxP training management,
• Preventative maintenance and calibration
For regulatory affairs, the software captures, manages and tracks all correspondences, product registrations, electronic signatures, submissions and commitments to all healthcare authorities. QMS is typically interfaced with other internal systems, such as ERP, to enable accurate and efficient data flow across business processes.
ERP is a mature product with universal adoption in the pharmaceutical industry. As ERP product “footprints” have grown, hundreds of system modules have been added to offer specialized functionality. ERP/QM, the suite of quality modules offered by leading ERP suppliers are generally designed to automate the quality processes of the supply chain and manufacturing functions. Typical ERP/QM capabilities are:
• Quality planning
• Supplier management
• Quality control
• Quality assurance
• Quality transactions throughout
In addition, batch record information, which is integral to both the manufacturing process and quality management, is typically recorded in the ERP system.
Fundamentally, QMS are designed to automate quality functions throughout the company, and are oriented around the recording, management and resolution of incidents. Fundamentally, ERP/QMs are designed to automate the quality activities within the supply chain and manufacturing, and are oriented around product and process data. These are important factors as they reflect the necessary priorities of the quality and manufacturing functions respectively.
Even though QMS and ERP/QM have different focus and orientation, there are a number of overlapping capabilities from each of these systems (See Figure 1 above). The overlap in capabilities is primarily in supply chain quality transactions and may include:
• Supplier management
• Supplier audit
• Quality control
• Batch records
• Analysis and reporting
• Calibration and maintenance
These overlapping capabilities that have emerged within these two quality systems have created some confusion in the marketplace among some of the functions within life science companies. This is because similar terms used for various capabilities within the two systems actually represent capabilities with somewhat different functionalities. For example, both systems show capabilities of quality control. However, the capabilities behind the term quality control for ERP/QM represent functions like SPC/control chart analysis and supplier qualification and evaluation. Quality control under this system is focused on the processes and transactions around procurement, production, final inspection and storage of product. Quality control for QMS represents broader capabilities that may relate to not only the product lifecycle, but also the enterprise, such as management and reporting of deviations, complaint handling, internal/external audits, change control and CAPA.