Too many virtual biotech companies are working with disjoined systems trying to manage a variety of contractors and vendors. While doing so, they are working to continually fund their manufacturing and clinical activities. To be successful in these efforts, a quality management system, such as InstantQMS™, that is attuned to the specific needs of an organization leveraging an outsourcing model allows virtual biotech companies to secure investor confidence, streamline workflows, and more easily achieve compliance.
Improve Investor Confidence
Venture capitalists know all too well the risks that come with the virtual biotech industry, and that the FDA holds virtual biotech companies accountable for the clinical trials they sponsor. Due to this, VCs carefully examine the processes and procedures virtual biotech organizations have in place. It’s common practice for investors to look at the operations and systems virtual biotech companies have in place to keep quality in control when outsourcing clinical and manufacturing activities. Virtual biotech companies that leverage a quality management system reduce risks by having one central location where there are documented standards and processes, which more easily ensures investor confidence.
Maintain FDA Compliance
As previously mentioned on the InstantGMP™ Blog, following protocols that prioritize quality is required by the federal government. The U.S. Food & Drug Administration mandates that virtual biotech companies have formal and heavily documented procedures in place for quality management, particularly through a quality management system. Such a solution provides end-to-end support for virtual biotech companies to track, document, and report on all outsourced manufacturing and clinical activities. This keeps data transparent, streamlines vendor and contractor management, improves oversight of outsourced workflows, and ultimately yields compliance and quality assurance.
Streamline Processes and Workflows
A quality management system that is attuned to the particular challenges facing virtual biotech companies is critical for efficiency. For some virtual biotech organizations, it is common practice for them to use paper based processes or a multitude of systems that are not interconnected. This creates friction, mismanagement, and high risk potential. When outsourcing and using a multitude of contractors and vendors, having one central location for documentation, workflows, and training streamlines management and oversight. One virtual web based system, accessible to all parties participating in manufacturing and clinical activities, allows for guided workflows, autonomous processes, accountability, and proper documentation for procedures.
InstantQMS™, includes built-in logs for incidents, change controls, audits, and training, allowing organizations to record all development, progress, and even adverse events during clinical and manufacturing activities. The tool was created by quality and regulatory experts who specialize in the FDA requirements that virtual biotech companies must meet.
Prioritizing a strategy toward quality management is the best line of defense for companies looking to secure funding, streamline oversight, and remain compliant and accountable. By investing in a QMS that is focused on quality and efficiency, companies can safeguard and reduce risks to withstand the many external factors influencing today’s virtual biotech industry. Want to learn more about how quality management can help you? Schedule a demo with our team of experts today.