With Qualio Plus and Qualio Plus Audit, Life Sciences Companies Have a Full Scope of Quality Management Software and Services and a Team with Nearly a Century of Combined Quality Management Experience
Qualio the trusted cloud quality management system software for the entire life sciences ecosystem — announced Qualio Plus and Qualio Plus Audit, two new service-based offerings that are empowering life sciences leaders to expedite go-to-market by streamlining a secure, end-to-end quality management strategy. To further support life sciences companies looking to accelerate speed and safeguard quality, Qualio also tripled the size of their in-house advisory team.
“Qualio is purpose built for emerging life sciences leaders that are focused on accelerating development of life-saving treatments and d**** for patients,” said Jen Baird, CEO at Fifth Eye. “The advisory team at Qualio is a true extension of our internal team. Without their easy-to-use platform and advisory services, our quality management strategy would have been challenged by unnecessary time constraints and inflated costs — all of which have the potential to impact patient lives and well-being.”
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With Qualio Plus, life sciences teams get Qualio’s best-in-class electronic quality management system (eQMS) and a team of trusted advisors with nearly 100 years of combined quality management expertise. Services offered with Qualio Plus include: hands-on coaching focused on streamlining the adoption of technology to support quality management; strategic guidance on quality management best practices; insights on relevant regulatory changes across the globe; SOPs and templates to comply with regulatory bodies such as FDA, ISO, and ICH; and quality assurance support.
The advisory team at Qualio, which is led by a quality management expert with more than 20 years of in-house life sciences experience, Kelly Stanton, also now offers a specific and cost-effective auditing service. Qualio Plus Audit includes eQMS and a full scope of services — as well as internal and supplier audit support services and gap analysis. With Qualio Plus Audit, life sciences leaders can decrease the likelihood of regulatory audit failures and issues, which can set go-to-market timing back significantly for life sciences companies, and reduce the need for additional outside consulting fees, which can add up to tens of thousands of dollars.
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“Quality management is a mission-critical but time-consuming part of the product development life cycle for emerging life sciences leaders,” said Robert Fenton, CEO and founder of Qualio. “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.”
This news follows Qualio’s recently announced product — Design Controls for medical device and software as a medical device (SaMD) companies. Design Controls helps medical device companies expedite time to market by seamlessly integrating product development and quality management in one workstream and automatically generating detailed documentation to support compliance and regulatory approvals.
Qualio’s now has more than 300 customers across the globe spanning the medical device, pharmaceutical, biotech, and contract service provider markets. For more insight on how Qualio can help streamline and safeguard quality management and accelerate the delivery of life-saving products that are safe and effective, visit Qualio.com.
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