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Sware Raises $6M to Accelerate Life Sciences Innovation by Automating FDA-Mandated Software Validation

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Press Release

Sware Adds AI Assistance to Res_Q Platform, Receives SOC 2 Type II Certification

Sware’s AI-supported tools and new certification affirm company’s commitment to deliver leading-edge technology for life sciences companies supported by industry best practices

September 3, 2024 10:00 AM EST  |  Boston  | 

Sware, provider of the most complete software validation solution for innovative life sciences, software, and technology companies today announced that it has added AI Assistance to its Res_Q™ platform, a GxP validation platform that helps life sciences and biotechnology companies automate, unify, and accelerate validation processes. It comes as part of a larger, major update (24.2) that offers users multiple functional and quality-of-life changes for reporting, document review, quality assurance, and more.  Additionally, the company received a System and Organizational Controls 2 Type II (SOC 2 Type II) certification following a successful external audit by Sensiba LLP, demonstrating strict systems controls in multiple domains including security, availability, and confidentiality.

Res_Q’s new AI Assistance feature helps users accelerate content creation and ensure consistency across document sets within the platform, making documentation and file management easier, faster, and more efficient. For example, a new AI-powered feature can now ingest and summarize large volumes of release notes, streamlining a core step in the validation process. The addition of AI Assistance to Res_Q is the first of several planned steps in Sware’s broader AI integration roadmap, which will focus on building Quality directly into AI-supported validation and supporting responsible use at all points in the GxP validation process.

Sware’s recently awarded SOC 2 Type II certification reflects the company’s ongoing commitment to upholding the highest quality standards possible in development, deployment, and operation. Notably, Sware’s SOC 2 Type II report did not have any noted exceptions and was therefore issued with a “clean” audit opinion from Sensiba. This indicates that Sware demonstrated an exceptionally high degree of rigor throughout the audit process.  

“Sware has always strived to implement high-value features rooted in unparalleled domain knowledge and proven best practices,” said Ellen Reilly, CEO of Sware. “The addition of AI Assistance to Res_Q, in tandem with our SOC 2 Type II certification, demonstrates our capability to deliver customers leading-edge solutions backed by exceptional rigor, knowledge, and service. We look forward to announcing new functionalities, including additional AI-based capabilities, as we continue to enhance the Res_Q platform.”

About Res_Q
Res_Q is a cloud-based platform built with an open API architecture that allows life sciences organizations to control all validation processes – for IT, manufacturing, lab systems, and more – in a single, highly scalable system. With intelligent risk assessments to initiate workflows and assign workloads based on risk profile, Res_Q puts quality at the forefront without sacrificing speed. 

About SOC 2 Type II 
Developed by the American Institute of Certified Public Accountants (AICPA), the SOC 2 information security audit provides a report on the examination of controls relevant to the trust services criteria categories covering security, availability and confidentiality. A SOC 2 Type II report describes a service organization's systems, whether the design of specified controls meets the relevant trust services categories, and – as a follow-up to Type I – assesses the effectiveness of those controls over a specified period.

About Sware 
Sware’s mission is to rescue life sciences companies from the grip of validation debt; the unpaid cost of release, testing, GxP, and business requirements. The Res_Q™ software platform offers the most complete validation solution available today. Res_Q eliminates validation debt and ensures peace of mind in an increasingly complex technology ecosystem. For more information, visit www.sware.com.

 


Media:

Colleen Burns
Colleen.Burns@sware.com

Nate_Mcbride
Nate_Mcbride
Nate_Mcbride

Nathan McBride
Senior Vice President, IT
Xilio Therapeutics

Nathan McBride
Senior Vice President, IT
Xilio Therapeutics

Nathan McBride
Senior Vice President, IT
Xilio Therapeutics


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