Qualio, a producer of cloud quality management system software for the life sciences industry, has made public the launch of Qualio Plus and Qualio Plus Audit, which are geared toward helping life sciences enterprises in streamlining secure end-to-end quality management strategies, hastening go-to-market times. The firm has also tripled the size of its internal advisory team to expand support for the new offerings and to assist clients by ensuring quality.
Qualio Plus provides life sciences teams with Qualio’s electronic quality management system (eQMS) as well as a team of advisors with deep quality management expertise. The service offers hands-on coaching, strategic guidance on best practices, global regulatory insights as well as compliant SOPs and templates, and quality assurance support.
Qualio Plus Audit offers eQMS in addition to internal and supplier audit support services and gap analysis, decreasing the possibility of audit failures and compliance issues. This helps prevent go-to-market delays and reduces the need for additional consulting services, leading to significant savings for life sciences companies.
Robert Fenton, CEO and Founder of Qualio, said, "Quality management is a mission-critical but time-consuming part of the product development life cycle for emerging life sciences leaders...As the number of innovative life sciences companies coming to market increases, the need for a purpose-built quality management platform and supporting advisory and auditing services is growing. The reality is these nimbler startups don't need high-cost, heavyweight software. They need easy-to-use technology and nimble services that will enable them to compete and best serve patients."
The announcement comes on the heels of Qualio’s new product, Design Controls. Built for the medical device and software-as-a-medical device industries, Design Controls prioritizes time-to-market by integrating product development and quality management into a single workflow and automatically generating compliance and regulatory approval-related documentation.
The company is dual-headquartered in San Francisco, California and Dublin, Ireland, providing a strong base in both North America and Europe. With more than 300 global customers in the life sciences, medical device, pharmaceutical, biotech, and contract service provider spaces, Qualio’s latest offerings stand to reinforce its position as a market leader in quality management services.