Uncovering the problem
When we started working on making quality management easier, we knew there was room for improvement, but we never expected that the scale of the challenges faced by companies would be so great. Through customer interviews a pattern became clear; quality management is a huge challenge, especially for small to mid-sized life sciences organizations. The solutions that exist are primarily focused on large enterprise sales. As a result, they are too costly, cumbersome and complex for smaller organizations to successfully implement and manage.
The most commonly used solution by smaller organizations is a cumbersome, inefficient and error prone hybrid paper based system, comprised of a forest of paper, and a mountain of Microsoft Word and Excel files. Furthermore, when getting started, most companies seek the help of experienced quality and regulatory (QA/RA) consultants to help them get market approval from organizations such as the US Food and Drug Administration (FDA).
Over 90% of the companies interviewed reported that they struggled to access the right QA/RA consulting expertise at a price point they could afford. This was mirrored by conversations with QA/RA consultants that said that they often found it difficult to provide their services to smaller companies. We developed Qualio to solve these problems.
Developing the solution
Our vision for Qualio is to be at the center of quality for regulated businesses, which increasingly every business is becoming. The beginning of this journey was developing an automated, integrated document control and training platform. Knowing that traditional software solutions were complex and difficult to use we had two primary goals for the initial release. Qualio had to be:
Be very easy to use and;
Put the user and the work they need to do at the center of the experience.
Customer feedback to date has been that we have delivered on that, and more.
Working towards a fully integrated, paperless future
Launching is just the start. Our vision for the future is much greater than building a document control and training platform. Within the next three years our goal is to create a 100% paperless, fully integrated quality management platform. We’re dedicated to going all the way with this. The benefits to such a system are self-evident. In addition to making effective quality management possible for organizations of all sizes, it will enable companies improve their ability to provide higher quality products and services to their customers. Everyone benefits from this
None of this would have been possible without the help and support of our customers, partners, and beta users. From all the team - thank you for believing in us. Special thanks must also go out to our fantastic team. They tirelessly worked at making this vision a reality. I'm honored to have the privilege of working with such talented individuals. This is just the beginning, the end of one chapter and the start of the next. We're looking forward to going on this journey with you.