Nowadays, with the advent of social media, we’re well aware that the pharmaceutical sciences industry is no stranger to the U.S. Food and Drug Administration’s breadth and wrath – and it doesn’t matter if it’s big pharma or emerging companies. In a past blog post I wrote about today’s increased regulatory pressures across pharmaceutical and biotech manufacturers and how the need to efficiently track and manage quality and compliance processes is more important than ever for consumer and business health. FDA’s inspections, warning letters and recalls will continue.
Regulatory pressures aside, with increasing competition across the industry, the importance of quality increases as well. Pharma SMBs (small and medium-sized businesses) can look to leading pharma organizations for best practices in quality and regulatory management. For example, using software to automate and streamline fundamental and required business processes like “big pharma” can help emerging companies achieve compliance, increase operational efficiency, and gain a competitive edge. Advanced systems can track, manage, and report on critical business processes such as deviations, complaint handling, supplier quality, internal and external audits, change control, corrective and preventive action (CAPA), and investigation and root cause analysis.
TrackWise SelectStart is an out-of-the-box EQMS solution based upon industry best practices for managing quality events. This packaged solution is a natural capability of Sparta Systems, with nearly two decades of experience across the life sciences industry. TrackWise SelectStart affords SMBs reduced cost of ownership through a total solution that includes software, a turnkey validation package, and a tailored services approach. Companies can deploy some or all processes in either a phased approach or as a holistic quality management system to ensure compliance, improve operational efficiencies, and reduce costs. To learn more, please contact us.