This article was first published in the Winter 2014 issue of OnWindows
Pharmaceutical companies across the globe must contend with numerous challenges. They face pressure to control operational costs, increase R&D investments and reduce prices for end users, and must also remain compliant with ever-increasing industry regulations.
For example, as the number of ‘pharmerging markets’ and the ‘patent cliff’ – a phenomenon prompted by patents for major prescription drugs expiring – continues to escalate, major pharmaceuticals will lose revenue to smaller players mass-producing generic versions of medications.
Meanwhile, amendments to legislations such as the Good Manufacturing Practices Chapters 3 and 5 will force pharmaceutical companies to improve quality control and develop dedicated facilities to address cross-contamination issues. Changes to packaging requirements will also significantly increase costs across the whole supply chain and subsequently raise product costs.
While essential, ensuring compliance and producing high quality products in a tightly regulated industry can be difficult. Most pharmaceuticals now have a quality assurance and quality control (QA/QC) department, with a quality management system to identify, monitor and prevent defects in processes and products. Using standardised operating procedures and policies, QA/QC teams help companies to meet production and regulatory requirements, while limiting instances of non-conformity across their supply chains.
The pharmaceutical industry typically approaches quality control reactively, implementing corrective actions to combat instances of non-conformity. This is often done manually, which can lead to data duplication and human error.
Instead, organisations should take a more proactive approach, prioritising product performance and quality from the start. This requires modern IT systems and integrated enterprise resource planning (ERP) solutions that provide full control over operational processes.
Our experience with companies that deploy our AX for Pharma solution – which leverages Dynamics AX, SQL Server, SharePoint and Office – indicates that it significantly improves the user experience and allows the QA/QC department to manage, update and validate the system in a controlled and cost-effective manner. The solution can also be combined with industry-specific systems to natively support many ERP and quality-related workflows. This ensures compliance with international regulations and guidelines from industry bodies, such as the Food and Drug Administration and the European Medicines Agency.
AX for Pharma is a fully integrated, off-the-shelf solution, with continuously-added new features and functionalities to help businesses remain compliant and at the forefront of the industry.
Andrea Ruosi is CEO of AX for Pharma
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