Sware Briefing Note
Axendia was recently briefed by the executive team at Sware, including Ellen Reilly, CEO, Bryan Ennis, Co-founder and Chief Quality Officer, Colleen Burns, CMO, and Brad Hainer, Head of Revenue. The team shared how Sware’s Res_Q and GxPNext platforms are driving innovation in the life sciences industry.
Sware positions itself as both a technology and service provider, offering a validation platform combined with consulting services to ensure organizations can successfully modernize their compliance processes.
The Shift to Cloud Based Validation
Validation has historically been a fragmented and cumbersome process. In Axendia’s blog post on the topic of Computerized Software Assurance, we point out that the FDA has recognized that current perceptions and approaches to computer system validation are a significant barrier to digital transformation and manufacturing modernization. In September 2022, FDA released the “Draft Guidance on Computer Software Assurance for Production and Quality System Software.”
CSA shifts the focus from checking documents to ensuring system functionality and patient safety, enabling organizations to reduce the time and effort required for compliance. By integrating CSA principles, companies can prioritize testing critical functionalities and leverage automation and AI to drive efficiency.
The move to cloud computing offers companies the ability to operate on standardized software versions, allowing for a more scalable and streamlined validation framework. “The world’s moved to the cloud, and it’s created a unique opportunity. Everyone is on the same base version of the software at the same time. That allows us to standardize and scale validation in a different way,” said Ennis.
Sware’s Res_Q platform is designed as an enterprise-class validation tool that addresses these changes, supporting computerized systems, equipment, process validation, and analytical methods. “By incorporating CSA-based methodologies, Sware enables customers to adopt a leaner, more efficient validation strategy while maintaining full compliance with regulatory expectations,” added Ennis.
Res_Q and GxPNext
Res_Q is designed for biotech, pharmaceutical, medical device, CDMO, and CRO organizations. Res_Q is centralized and supports compliance with 21 CFR Part 11- and EU Annex 11-that facilitates a structured validation process. The platform offers risk assessment, electronic test execution, project management, and audit-ready documentation.
The Res_Q platform provides:
- Integrated risk assessment to help companies focus on critical areas of validation.
- Electronic test execution that allows for real-time tracking and automation of validation steps.
- Project management tools that enhance visibility and coordination across validation teams.
- Audit-ready documentation to streamline regulatory inspections and compliance efforts.
- A marketplace for pre-configured content, allowing users to accelerate validation by leveraging industry best practices and standardized templates.
“One of the biggest impacts we hear from clients is that they no longer have to dedicate extensive resources to manual validation tasks. Instead, they can focus on innovation, regulatory alignment, and accelerating time to market,” explained Hainer.
“To keep pace with evolving regulatory requirements, life sciences companies should consider adopting real-time validation intelligence, audit-ready documentation, and predictive quality insights. These capabilities enable Quality and IT teams to break down silos and transition from reactive compliance management to a proactive, risk-based approach. By centralizing validation tracking, monitoring deviations, and enhancing traceability, organizations can streamline audits, reduce compliance risks, and ensure alignment with GxP and 21 CFR Part 11 standards. To support these efforts, Res_Q provides dashboard KPIs that simplify reporting requirements while enhancing control over compliance activities, providing greater efficiency and visibility.”
Tailored for software vendors, GxPNext enables product validation and supports IQ/OQ/PQ processes, helping vendors support regulatory obligations.
The GxPNext platform:
- Ensures compliance with industry regulations by managing validation from software release to customer deployment.
- Supports automated validation workflows, reducing manual effort and improving efficiency.
- Integrates with ALM (Application Lifecycle Management) tools like Jira, Tricentis, and Selenium to streamline the validation of new software features and updates.
Axendia’s market research, The Costly Impact of Ineffective Requirements Management in the Medical Device Industry, found that 58% of companies reported their products often or always require rework before release. The research also revealed the two primary causes are incomplete traceability and inadequate verification. These insights highlight the critical need for robust requirements management systems.
Advanced digital validation solutions, such as GxPNext, can address these challenges by automating compliance processes, improving traceability across the product lifecycle, and ensuring verification is thorough and consistent. By leveraging such technology, companies can minimize errors, reduce the need for rework, and enhance product integrity, ultimately streamlining development and accelerating time to market.
“For many software vendors, validation is still a struggle—whether due to a lack of expertise or tooling. Companies are increasingly looking to their vendors to support more of the validation obligation and generate higher-quality evidence. By enabling software vendors to integrate validation directly into their SDLC (Software Development Life Cycle), Sware’s tools reduce friction and increase compliance efficiency while helping companies bring new innovations to market faster,” said Ennis.
In Brief
The life sciences industry is undergoing a shift in how validation is approached, with cloud-based solutions, CSA principles, and AI-driven automation redefining compliance processes. Companies face ongoing challenges in balancing efficiency with regulatory requirements, making the integration of risk-based validation essential for future success.
Platforms like Res_Q and GxPNext support this transition, offering a pathway to streamlined and scalable validation strategies. As regulatory expectations evolve, organizations will need to adapt their validation methodologies to maintain compliance while enabling faster innovation cycles. The continued adoption of digital validation solutions will play a crucial role in shaping the industry’s future.
We will continue to provide updates on Sware as they become available.
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The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.