Digital Validation: A Technology Solution You’ll Sware By
Cutting-Edge Regulatory Compliance | Trust & Transparency
By Bryan Ennis
President & Co-Founder, Sware
How do you transform an industry – especially one as critical as life sciences, with its acute need for regulatory compliance? Sware, Inc., formerly Boston Technology Research (BTR), is doing just that. Using paper (and digitized paper) to manage validation is leading to wasted time, effort, and money. It’s time for a change. We are at the forefront of a digital transformation, as the entire industry is moving from documents to data, from silos to integrated workflows, all in a compliant, regulated cloud. Today, our clients are leveraging the power of validation automation to achieve cutting-edge regulatory compliance.
It's an opportunity to take a giant technology leap forward.
We are automating every part of the validation process at Sware, ultimately enhancing patient safety. Since validation is complex and ubiquitous in the life sciences industry, we are unraveling 25 years of processes and replacing them with new, efficient technology. Over the next 10 years, the industry will be transformed, as a critical mass of people learn to do things in new ways, thanks to our digital validation software.
What is digital validation?
Digital validation plays a special role in all regulations of the good practice (GxP) environment. Fundamentally, a digital validation tool provides documented proof that a process continuously produces a product that meets defined quality assurance specifications. Using a digital validation solution significantly reduces manual effort, time, and risk by automatically ensuring that systems and software within the life sciences industry, including the medical technology and the pharmaceutical industry, meet stringent regulatory requirements. The primary goal of digital validation workflows is to prevent any risk of human error during the production process.
This evolution from paper-based review processes and physical documents to digital documents and electronic workflows enables validation professionals to improve processes through effective version control and audit trails. Rely on digital validation to help you maintain the rigorous standards in the industry.
Digital Validation Delivers Value.
Cloud-based technology offers tremendous value to the life sciences industry in terms of global availability and a “work from anywhere” culture. Existing companies have been working to transition their regulated systems into the cloud, and almost all new companies are entirely cloud-based at the start. However, today’s swift pace of innovation means that software companies can introduce new capabilities faster than ever before. Validation is an impediment to keeping pace with changing technologies and staff assimilation of new features.
Small-to-midsized businesses don’t have the staff experts to stay compliant as they manage today’s volume of software releases across their systems, and even larger companies struggle with the burden. Think of 30 releases needing to be deployed across multiple platforms at once. Having a technology solution provider with a purpose-built platform for this challenge offers a new toolset for compliance while mitigating stress, work, and risk. Sware delivers advanced capabilities along with increased efficiencies.
Where did we come from? My co-founder Kosal Keo and I came up through Genzyme, where we managed validated technology. Our roles often meant pulling together data across 70 pieces of software, and we saw first-hand the circuitous paths of technology in regulatory compliance. These limitations were holding us back from deploying better capabilities to speed innovation. We wanted to help fix the problems and do our part to improve public health, so we formed the vision for Res_Q™ as the platform that would move validation beyond paper into a completely digital, automated, and easy-to-use solution.
Today, Sware has partnered with more than 275 life sciences companies to help them adopt solutions in the regulated cloud. We’ve been there; we know that validation is hard work. That’s why we built the platform we wish we always had. Combining digital validation technology with our deep domain expertise, we can reduce staff time spent validating by about 80%.
We’re making validation paperless, seamless, and stressless.
What’s the future of Sware and regulatory compliance technology? We envision reducing the time it takes life sciences and software companies to deploy and implement innovations from months to days to hours. We see near-term opportunities around AI applied to compliance and validation technologies.
On a broader scale, we anticipate a continued homogenization of healthcare. As an industry, we have only scratched the surface of possibilities with pharmaceutical drugs, devices, and combination products; innovation will shift to encompass nutrition and human development. Data will be available and usable everywhere in the broader, connected healthcare system, including the private and public sectors. Our team will be there to help ensure these new products are ones you can trust – even Sware by.
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