Innovations in science, manufacturing, and technology have led to the development of millions of products that we use every day. From pharmaceutical drugs to medical devices to consumer products, these products have fundamentally changed our lives and created industries worth trillions. A critical factor in creating, testing, and deploying such products is quality management. This is important to not only create safe and reliable products but also required by regulatory authorities like the FDA and ISO. As a result, Quality management has grown tremendously over the years.

Hundreds of thousands of products are regulated by the FDA and other agencies. Despite the importance of Quality Management and the development of software solutions to manage the relevant processes and regulatory requirements, there are unfortunately numerous safety alerts and product recalls. At the same time, technological advancement has created a long tail of small biotech, and medical device companies, that can’t afford expensive Quality Management Systems(QMS) or human resources with the know-how to use and manage them. Additionally, the companies also struggle with the regulation in the industry. This has created a perfect storm where manual and inefficient processes have taken root in an extremely important industry.

This is the problem that Qualio was built to solve.

“Qualio lets me be in a state of control” — Customer

Challenges
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Quality management is a broad and comprehensive process that covers all activities required to build, test, deploy, and maintain a product. In many cases, rigorous regulations oversee the entire development and commercialization, especially in Life Sciences. The challenges in Quality Management are many

Complexity- As seen above, the Quality management system touches every aspect of the product development lifecycle. Design, production, testing, change management, training, marketing, risk management, vendor management, equipment control, and complaint management teams must seamlessly collaborate and respond to changes. As a product line and the overall company grows, more people and processes are added to the mix, and the system must ensure that quality is maintained in a consistent and transparent manner.
Collaboration — A key component of the Quality Management System is the ability to collaborate quickly and easily. Since many teams with different objectives are involved, a QMS needs to be adaptable to everyone’s requirements without creating the need for complex deployments, long training sessions, and arduous controls to collaborate in real-time.
Mission Critical — Quality is the responsibility of every team that is working on a product. The system must comply with regulatory requirements. Any missteps here can lead to significant delays in launching the drug, therapeutic, or device.
As a result, the QMS must be comprehensive, flexible, easy to use but also rigorous. The problem is that most solutions in the market today only cover portions of the product development lifecycle. They were developed many years ago, are complex, expensive, and difficult to manage. They were also not designed to be cloud-native with a modern architecture that is agile and easy to scale.

The situation is made worse by changes in the industry. Increased M&A activity has highlighted the problem of integrating multiple quality management systems. Advances in technology and a focus on analytics and data-driven approaches have also increased the diversity of products and the regulatory scrutiny that comes with it. As a result, most companies try to stick with paper or basic solutions like Sharepoint to keep things simple rather than modifying complex QMS deployments. Predictably, this leads to significant inefficiencies and problems down the road.

“Most companies don’t have good quality systems” — customer

One System to Rule Them All
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Qualio addresses precisely these challenges. It is a one-stop solution that was designed for Quality teams and to help create, deploy and manage products in a compliant and safe manner

Comprehensive — The Qualio product provides end-to-end management of the quality features including dashboards, document management, training, reports, quality events, and change management. A key strength of the platform is flexibility and automation. Qualio is designed for teams to quickly build, share, track, and update processes rapidly and then automate them so minimal training is required in the future. This vastly improves the speed and sophistication of quality management.
“People live in the product and review everything in it” — Customer

Intelligent — Since Quality Management encompasses diverse teams, Qualio was built to be intuitive and easy to learn. A huge set of integrations and pre-built templates enable teams to onboard quickly and collaborate in real-time. The platform also provides a rich suite of analytics and insights that can detect issues early and help the organizations scale rapidly.
Compliant — Finally, compliance is a central component of Qualio. Risk management, complaint handling, audit, review, and corrective actions are all pre-setup with templates so companies, big and small, can manage all their regulatory and compliance requirements effectively.
“Qualio is the source truth for an inspection” — Customer

These and many other attributes have enabled dozens of Qualio customers go-to-market faster and in a safer and more efficient manner.