Creating a State of Inspection Readiness
We’re delighted to share a recent Spotlight Blog interview with life sciences industry veteran in regulatory systems Bryan Ennis, Co-founder & President at Sware. Learn how Sware wants to change how the life sciences industry manages validation.
Please tell us about your background.
I have more than 20 years’ experience in life sciences and technology, selecting, implementing, integrating, and validating regulatory content management applications.
Before Sware, I was the global expert in software compliance at Veeva where I led the development of compliance programs to support regulated customers. I founded Veeva’s R&D Customer Success program and also led retention efforts as the company scaled from three to 300+ customers. Prior to Veeva, I was the head of Global Regulatory Systems at Genzyme.
I was a graduate-level Professor of Telehealth at PACE University in New York City, and I am currently an active industry speaker and subject matter expert in the areas of regulated cloud solutions, computer systems validation, and emerging healthcare technology.
Please provide a brief overview of your company.
Sware is a regulatory technology company that was founded to change how the life sciences industry manages validation. Sware provides one validation solution crafted specifically for the life sciences industry. Our key platform, Res_Q, automates validation workflows and data flow – effortlessly navigating through each step of the validation process for both GxP and non-GxP systems. Coupled with our Marketplace of pre-built release packages and managed services experts, Sware’s solution increases the value of technology investments by enabling end users to turn on more features and get more out of the promise of today’s technology. The days of not turning on new software features so as not to have to deal with more validation work belong in the rearview mirror.
Sware’s solution increases the value of technology investments by enabling end users to turn on more features and get more out of the promise of today’s technology.
Based on your experience, what do customers routinely struggle with in regards to validation and areas of inefficiencies?
All life sciences companies following GxP principles are required by regulators like the FDA to validate that the computer systems they use operate as intended. Today, validating those regulated systems is still primarily done with a hodgepodge of email, paper-based documents, spreadsheets, and a lot of white knuckling by individuals. This creates huge burdens for life science customers regarding releases of GxP-relevant software and maintaining a compliant state. It’s not that life science customers can’t validate their systems. Where they struggle the most is keeping up with the volume of work as they add more GxP systems.
How does your company solve these challenges?
Sware’s platform, Res_Q, automates, integrates, and scales compliance processes across organizations. With Res_Q, customers can develop and maintain digital first processes according to their SOPs and risk profiles. Quality teams are able to create documents, execute test scripts, collect testing evidence, submit content for review, and complete 21 CFR Part 11 compliant signatures all in one central hub, purpose built for validation activities. Software providers for the regulated space in particular can make it easy for customers to ingest release documentation, assess the risk of new features, take credit for work already done, and validate new releases.
We aim to eliminate version control concerns, disjointed workflows and the lack of visibility associated with traditional, document-centric validation processes.
Our customers can ensure consistency in compliance across their organization and reside in a state of inspection readiness.
Where has your company seen success?
Over 25 life science customers and regulated software providers are today leveraging Res_Q to validate their regulated computer systems, facilities, and equipment. HUYABIO and Modicus Prime are two examples of companies we are partnering with to bring about a different way of managing validation