Our Investment In Qualio: A New Breed of Quality Management System for Life Sciences
Across life sciences, a quality management system (QMS) is critical for both regulatory compliance and continuous product innovation. It has become the cornerstone of regulated life sciences companies that require documentation to gain approval from the FDA and ensure compliance with regulatory standards once a product is in commercial circulation. This applies to the entire product lifecycle once a product is made or a molecule is discovered. The system documents all the procedures and records needed to ensure products are safe, perform as intended, and comply with the required regulations.
I’m excited to announce our investment in Qualio as it expands accessibility of its QMS and services for life sciences customers across the globe and builds towards its vision of becoming the “Quality Operating System” for life sciences. Unlike companies in other industries, life sciences companies have a very high burden of proof not just on the efficacy and safety of their product but also the quality and consistency of production.
Qualio is a quality management SaaS platform that was founded by CEO Robert Fenton. It helps regulated life sciences companies track and maintain quality records and data to comply with regulation mandated by the FDA and certifying bodies like ISO. In the past, large life sciences companies have had QMS but the rest of the ecosystem was getting by with pen and paper or simple homegrown systems like document storage in Google Drive and Box. However, the compliance burden has increased and a lack of a robust QMS to manage these quality processes could hamper time to market. To keep pace with industry innovation, modern life science companies simply can’t afford to have inefficient quality management slow down product accessibility. Not to mention, quality problems could lead to a “lights out” scenario if the regulators felt like proper controls weren’t in place to ensure quality and safety for patients and consumers.
Qualio addresses these various pain points by serving the life sciences ecosystem with a more modern, cloud-based tool that integrates with other existing systems to automate a number of workflows. Its QMS unites teams, processes, and data all in one place so its customers can develop, launch, and scale life-saving products.
Qualio has all the elements of the Menlo “Trifecta”; three attributes which guide our investment in SaaS companies:
1. A clear wedge to modernize antiquated but critical workflows
Qualio replaces homegrown systems of tools stitched together to create manual processes. This is especially risky in quality given how important the function becomes for life sciences.
2. The opportunity to build or embed proprietary data into a system of record
Quality process documentation, training certifications and performance data is written directly into Qualio and it leverages integrations and open APIs to ingest data from other systems of record to combine into a single pane of glass containing all audit trails for regulatory compliance.
3. The potential to extend into multiple applications
As life sciences becomes a more distributed ecosystem with increasing regulatory burdens Qualio can serve as the quality “clearinghouse” to facilitate data exchange between customers and suppliers.
I met Robert in the throes of the pandemic and was immediately drawn to his vision and sense of purpose. His background and commitment to the mission of “enabling teams to launch and scale life-saving products” is inspiring. There are times when you meet a founder and realize they are special — you want to be part of what they are building — and this was certainly one of those times.
Over the past 12 months, Qualio has experienced unprecedented customer demand. The company now has more than 250 customers across the globe, spanning the medical device, pharmaceutical, biotech, and contract service provider markets. It counts the likes of Linical, Synthego (a Menlo portfolio company), Proscia, and Recursion Pharmaceuticals (another Menlo portfolio company) as customers. Customers also include notable organizations such as Medable, Paula’s Choice Skincare, Proscia, and Ginkgo Bioworks.
Our investment in Qualio aligns with our thesis surrounding vertical SaaS. We’re starting to see the emergence of business-defined applications that are built to serve the purpose of specific industries. Life sciences is notorious for having compartmentalized critical workflows which are siloed and constrained. Effective workflow management can reduce the potential for errors, help to ensure compliance with industry regulations and improve the quality of life-saving products brought to market. Qualio’s QMS platform reduces friction in this process and automates workflows at every step of the way.