Robert Fenton, Founder and CEO, Qualio
Robert Fenton, Founder and CEOThe most successful companies in life sciences are those with a quality-driven culture and the right tools to automate and scale their quality processes. However, for the majority of the businesses in this space, the act of ensuring quality work pushes against the velocity at which they can move and innovate.

The reason? Quality management practices or systems can easily break down due to the sheer number of people and locations involved in the process—which is generally expanded beyond a single-site and a few dozen employees. On the one hand, we have companies in the early stages, struggling to figure out how to ensure quality due to lack of expertise and a pre-built “quality playbook” that can be followed. On the other hand, there are companies at later stages of the business with many teams, locations, processes, and technologies, who suffer due to the fragmented nature of their workforce. Though modern life sciences firms have an option to outsource QC and QA process wherein, they can gain access to a lot of data, what to do with it is a question that goes unanswered. What is the result of such cases? Significant risks.

Mainly, companies may fail to get their products to comply with the requirements of regulatory authorities that are necessary for approval, which subsequently impacts their time-to-market, and top/bottom-line revenue.

While “quality is a prerequisite” in this line of work, innovation is a necessity for survival. So how can companies solve these issues and bridge the gap between the two? How can clinical, senior management, discovery, and regulatory teams focus on what they need to execute while building quality into the process? The answer is simple; implement a quality management system from the outset!

“Quality should not get in the way of velocity, they should complement each other. It’s a promise similar to the Hippocratic Oath that doctors take,” says Robert Fenton, Founder and CEO, Qualio. “Collaboration, automation, and linked processes are some of the non-optional ingredients in a quality-driven culture. And that’s what we aim to offer.”

Scalable, Robust, and Easy-to-Use

Founded in 2012, Qualio is the first cloud-based eQMS that helps simplify quality management for life sciences organizations that develop, produce, and distribute pharmaceuticals, medical devices, and biotechnology products. By optimizing and automating critical and complex quality processes, Qualio addresses the growing need for a flexible, secure and scalable quality management system. Built from the ground up, the solution comprises all the required tools for organizations to proactively eliminate defects, excel at audits, and achieve the business benefits of quality-driven growth. It offers closed-loop insights for continuous improvement and risk management alongside robust features for automation, enabling companies to bring products to market quickly.

Qualio’s eQMS offers key components—Dashboard, Document Management, Training, Quality Events, Suppliers, Design Control, and Reports—that make it the most robust and sought-after platform to choose. Dashboards are personalized for the user and focused on the actions that a particular user needs to take. When users log into their systems, the dashboard displays everything that's actionable and unique to their account.

Qualio: Quality Management - Simplified!

Quality should not get in the way of velocity, they should complement each other. It’s a promise similar to the Hippocratic Oath that doctors take

For document management, Qualio helps users handle everything from drafts all the way through periodic reviews and through retirement. Users can easily arrange and search by document type, title, group, and tags using comprehensive filters or an open search query. The process of creating and managing documents, assigning users and permissions, managing change control processes, and sending for Part 11 Compliant signatures are simple and easy, yet very powerful. For example, Qualio uses templates rather than old school modules. While modules work well out-of-the-box, templates offer greater flexibility as regulations and business need change—which happens constantly and rapidly. Templates allow users to create steps, processes, and document types within the structure the company needs. Moreover, under no circumstance is the data deleted given importance during an audit trail.

Training is another feature Qualio’s customers love. In just moments, an admin can add/assign training, and manage everyone regardless of the proof level, individual level or document level. For the user, training is a simple three step process—read the training, complete the assessment and sign off. From the training dashboard, the admin can see the snapshot of training activities for the company and focus on what matters based on what’s completed, due and overdue.

Handling post market surveillance and managing quality events also becomes very seamless with Qualio. Users can monitor audits, complaints, deviations, and more with easy-to-read dashboards equipped with sorting and filtering options. They can create new complaints using templates wherein they’d have to just add the details and tie the complaints to SOPs, CAPAs, or anything else for full traceability with risk management baked right into the system.

Both ISO and FDA regulations require organizations to have supplier management processes in place. With Qualio’s Suppliers, you can add your team’s Suppliers one by one or in bulk, manage reviews, and enable full auditability of your Suppliers. Within each supplier, you can also add a review by date to ensure your team’s compliance. Suppliers makes tracking your active, overdue, and archived suppliers a breeze.

With Design Control, you can connect systems like JIRA, Github, and more to Qualio and populate your requirements, tests, and risks in one place, enabling full traceability across the systems used by your Product, Engineering, and Quality teams. With your product information in one place, identifying gaps, mitigating risks, and preparing quality artifacts for release has never been easier. In fact, all your product information is pulled into a release with one click to share internally with your teams or with external partners.

Last but not least are the reporting capabilities. Qualio provides a variety of reports for greater visibility across the organization. Users can view activities happening across the system to stay on top of trends and behaviors. They can receive automatic notifications when documents or processes are up for periodic review.
Also, users can account for all changes in the system and maintain an automated audit trail across the system for enhanced visibility.

Innovation at its Core

Though Qualio is targeted for small to mid-market organizations with aggressive growth goals seeking an affordable solution for comprehensive quality management and compliance, its flexibility and transparent pricing models are designed to accommodate the needs of even enterprise-level companies. It is the only eQMS designed specifically for startups, scaleups, and SMBs in the life sciences industry per FDA cGMP, and ISO requirements for pharma, biologics, and medical device manufacturers.

“Our promise to our customers is that Qualio is the most trusted, scalable, and easiest to use quality platform on the market. To keep our brand’s promise, we have made significant investments into our engineering, product, and customer success teams. Our engineers meet regularly with customers to discuss new developments and features,” says Fenton. In fact, the company’s commitment to quality, transparency, and continuous improvement for customers has helped them achieve their ISO 9001 certification. He continues, “I wish I could say there was some secret ingredient, but it’s simply having intentional communication with customers and fueling a culture of curiosity and ownership—where product and engineering teams feel empowered to solve customer problems and build a relationship with customers.”

The Way Ahead

The eQMS category is growing at a rapid pace, which will only accelerate in the future as more investors and entrepreneurs enter the life sciences industry, including many new organizations outside the USA. Though it’s exciting to see new innovations come to market and help save lives, most of these companies are unaware of the time-intensive and costly process it can be to meet regulatory requirements. New compliance solutions, like Qualio, can help these companies and entrepreneurs meet FDA and ISO standards so they can get to market faster and scale.

Also, new development of products known as Software as a Medical Device (SaMD) are popping up around the globe and while they must meet the compliance standards of a hardware device, they bring in new challenges for regulators who are unfamiliar with a software company’s tech stack and agile processes. This has influenced the solutions and services Qualio offers to allow not only better integration, monitoring, and alerting into these tech tools but also services that can help software developers and founders navigate the complexities of regulations and De Novo applications. Velocity and quality have been opposing forces in product development in life sciences, they should not be and Qualio is working to change that.

“In our industry, only the most trusted, scalable, and easiest to use products will thrive in the coming years. And Qualio is uniquely positioned to be that brand. Even during the pandemic, we have helped several companies with employees working from home switch from paper-based to an eQMS. We expect the need for digital-based solutions to take over as the work environment continues to evolve post-pandemic. Needless to say, our platform will be regularly optimized based on customer feedback and the evolving landscape of compliance requirements and regulations,” concludes Fenton.