An electronic Quality Management System (eQMS) is the key in today’s world for preventing quality issues that can have life or death consequences for patients. Companies with tremendous potential in the regulated pharmaceutical industry can fail badly if they do not implement the right eQMS. Yet organizations that easily implement automated systems for many other functions often do not have an adequate eQMS in place. This is usually because the need for an eQMS is not understood early enough.
Everybody knows that Quality Management is an ethical and regulatory obligation for any company in the pharmaceutical industry. The FDA[1] has squarely put the responsibility on senior management for managing the quality of their products, services, and data. However, it can be challenging to understand what Quality Management means in the big picture, and how to effectively practice it.
A Quality Management System (QMS) defines the standards, strategies, and deliverables for achieving quality goals. A QMS starts with controlled policies, processes, and procedures that govern its activities, and formal employee training on relevant materials. Additionally, any QMS should govern Corrective and Preventive Actions (CAPA) to address issues and defects, as well as the management and conduct of audits to ensure compliance. Companies are now also using their QMS to govern Change Control (at the company process level, not just system level) and Risk Assessment as required by the FDA Guidance for Industry Q10 Pharmaceutical Quality System . This provides a higher level of risk-based quality management that regulatory agencies expect, and that companies need just to compete.
Most companies start off managing QMS tasks manually because they do not foresee the upcoming challenges. However, manual processes can become excruciatingly tedious and labor-intensive as companies grow beyond the startup phase. Highly paid employees waste precious hours printing, signing, scanning, and mailing documents to the Quality department. Quality, in turn, struggles to assemble, store, and retrieve paper records across multiple locations for audits or analysis. Spreadsheets and disconnected systems turn out to be passive data silos requiring redundant data entry, reconciliation, and heroic attempts at extracting and integrating data. Human errors abound and quality issues quietly proliferate while employee morale, productivity, and chances for improvement sink like an overloaded ship. Yet decision-makers often ignore these issues, because they can be hard to track or quantify. Eventually, quality issues explode without warning, resulting in catastrophic failure.
Fortunately, control over all QMS processes and records can be effectively and efficiently managed in a using an eQMS that scales up with the organization. Integrating Document Control and Training provides the most value initially, followed by CAPA and Audit Management. Integrating Change Control and Risk Assessment provides a single source of truth regarding Quality. Enhanced compliance, data integrity, management control, productivity, and higher morale can more than justify the cost—provided the right system is properly chosen, implemented (often in steps), and managed. This is not just crucial for success, but ultimately critical for company survival.
Choosing and implementing an eQMS has many challenges. Executive management support is critical throughout the process. A good QMS foundation that includes vendor management and vendor auditing processes should be in place initially. It is also prudent for executive management to use outside consultants with the experience and background needed to choose and establish an eQMS. Every organization must determine its own unique needs before selecting a vendor and system, as well as determining when to implement, and which modules. Any outside expert needs to respect that and work collaboratively to help the client make these decisions.
About the author: Sourav (Neil) Banerjee is a Quality Assurance Director with 21-year track record of protecting patient safety and data integrity, with experience in Big Pharma, CROs, and Software vendors. He has worked with AstraZeneca, IBM, ICON Clinical, Forest Labs, Veeva, and RxLogix. Sourav has presented at DIA on Data Integrity and PV systems, and helped train SFDA inspectors in China. As a Director of Quality, He has led eQMS implementations from the ground up. He started QMSintegrity in order to help companies develop and run world class Quality Management Systems.