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Featured Whitepaper

How to Transition to
Validation 4.0

The International Society for Pharmaceutical Engineering (ISPE) is providing guidance and best practices to achieve its vision for Pharma 4.0, a future state where organizations leverage the full potential of digitalization to provide faster innovations for the benefit of patients. Our industry’s current approaches to validation are viewed as a key barrier to making the transition to Pharma 4.0 successful.

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Library

Browse our growing collection of whitepapers, articles, media mentions, press releases, and one-sheets, curated to keep you informed on the latest across validation and compliance in life sciences.

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ARTICLEValidation 4.0: How to Avoid Document-Centric CSV Traffic Jams

Traditional document-centric CSV is now two digital transformations behind leading-edge technology, as the industry still struggles to first leverage the cloud for validation and second artificial intelligence.

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ARTICLEThree Ways Life Sciences CIOs Can Prioritize Validation 4.0

For life sciences chief information officers (CIOs), digital validation is often treated as an afterthought. However, validation is an integral part of the foundation of any life sciences business.

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ARTICLEAdvancing the Transition to Computer Software Assurance:

Responding to the FDA Draft Guidance for Production and Quality System Software

This article was published in the Summer 2023 edition of Update Magazine – FLDI’s quarterly member magazine – and shared with permission of FDLI.

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ARTICLETransitioning to Validation 4.0: A Roadmap for the Journey

Pharma 4.0 is a future state where organizations leverage the full potential of digitalization to speed innovation for the benefit of patients.

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ARTICLEThe Business Imperative Of Validation As A Forethought In Life Sciences

The life sciences industry is on the precipice of a new frontier—a future that is digital-first and technology-led. 

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ARTICLELessons Learned: Leveraging Pandemic Pandemonium for a Better Future

Though challenging, the pandemic provided the pharma industry with many opportunities for growth and continued learning.

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ARTICLEArchiving and Validation: Leading With Digital in Life Sciences

With industry-wide adoption of Software as a Service (SaaS) cloud systems, digital transformation is a key business driver today, improving efficiency at scale unlike ever before.

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BLOG21 CFR Part 11 Basics: Connecting the Dots From Regulation to Compliance in the Life Sciences Industry

You’ve probably heard of 21 CFR Part 11, the regulation that controls electronic records and electronic signatures. However, maybe you are new to the pharmaceutical industry, life sciences software solutions, or computer system validation in the pharmaceutical industry.

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BLOGRes_Q and AI: Modicus Prime Image Analysis for Quality Assurance

What will AI breakthroughs mean for pharmaceutical companies? We asked our first client dedicated to AI, Taylor Chartier, CEO/Founder of Modicus Prime, to share her perspectives.

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BLOGCSA vs CSV: What a Difference One Letter Can Make!What is Computer Software Assurance? And how do Computer Software Assurance and Computer System Validation compare in terms of effectiveness?Read More
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BLOGAutomating Software Validation: "Been There, Needed This"Working in the quality and compliance industry, I needed a software application to solve my everyday challenges. There weren’t good solutions available, so we set out to build a platform that we ourselves would want to use.Read More
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BLOGLife Sciences: Regulatory Issues on Your Radar Screen

Can a new, risk-based, critical-thinking approach help you gain altitude with your computer systems validation (CSV) process? With the life sciences industry’s widespread adoption of Software as a Service (cloud-based) systems, the struggle is real.

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BLOGEmbracing Equity Naturally: Lessons Learned from My Dad

My dad passed away coming upon 28 years ago, and there are three times during the year that strike me hardest with thoughts of him: in June (as he passed away 10 days before Father’s Day), in November (his birthday month), and in more recent years in March.

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BLOGDigital Validation: A Technology Solution You’ll Sware By

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. 

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WHITEPAPERHow to Transition to Validation 4.0

The International Society for Pharmaceutical Engineering (ISPE) is providing guidance and best practices to achieve its vision for Pharma 4.0, a future state where organizations leverage the full potential of digitalization to provide faster innovations for the benefit of patients.

Read More
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WHITEPAPERMoving Beyond Paper-based Validation – An Industry Transformation

Over the last 10 years, the majority of life sciences organizations have successfully transitioned their regulated systems into the cloud, and almost all new companies are entirely cloud-based from the start.

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WEBINARRAPS Webcast: Managing Change in AI-Based Systems

In this webcast presented by RAPS, join Kosal Keo, Taylor Chartier and Timothy Hsu as they reflect on the upsides and the concerns around AI and delve into a pragmatic discussion centered upon validating and managing changes in an AI-based system.

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FIRESIDE CHAT - PEER PANELDigital Validation: Bringing Together Quality & IT

Join Bryan Ennis, Sware co-founder and CEO, as he leads an engaging discussion among a group of your validation peers exploring digital validation trends and how quality and IT can best work together for a brighter future.

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FIRESIDE CHATHow to Transition to Validation 4.0 for SMBs

Watch Sware co-founders Bryan Ennis and Kosal Keo as they discuss how SMB organizations can successfully transition to Validation 4.0 and realize organization-wide benefits. 

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FIRESIDE CHATThe Future Trends of Digital Validation

Watch Sware co-founders Bryan Ennis and Kosal Keo sit down to discuss the current GxP systems compliance landscape and ruminate on future digital validation trends - including the challenges and benefits as the industry moves forward.

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ONE-SHEETRes_Q – The Validation Automation Platform for GxP Systems

Sware’s platform Res_Q automates, integrates, and scales compliance processes across organizations – enabling painless adoption of emerging technologies for healthcare, life sciences, and SaMD companies.

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ONE-SHEETSware Overview

Our mission is to help reduce risk to patients by transforming how the life sciences industry manages compliance of regulated technology solutions.

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ONE-SHEETSoftware Partners

Whether software applications are designed to support drug discovery and clinical trial design, or next-generation medical devices, the truth is compliant software validation is complex, time-consuming, and expensive. 

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ONE-SHEETxSMB Services Overview

As an early-stage life sciences company, building a solid foundation for quality is critical for the growth of your organization.

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ONE-SHEETSMB / Enterprise Services Overview

For all life sciences companies, a culture focused on quality is critical not only in your daily activities, but also for the continued success of your organization.

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PRESS RELEASESware Partners with Verista

We are excited to announce that Sware is partnering with Verista to help life sciences companies realize Pharma 4.0 by providing advanced and innovative digital validation solutions.

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PRESS RELEASESware Partners with Benchling

We are excited to announce that Sware is partnering with Benchling to accelerate digital R&D transformation for biotechs globally — by enabling adoption of modern software, purpose-built for science.

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PRESS RELEASEBTR rebrands as company that life sciences and healthcare innovators can Sware byLeading digital validation company, BTR (Boston Technology Research), announced today a rebrand and name change to Sware, Inc.Read More
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PRESS RELEASEBTR (Now Sware) Raises $15 Million in Series A RoundSware raises $15 million in a Series A round led by New York-based global venture capital and private equity firm Insight Partners, with participation from LRV Health, NewStack Ventures and other investors. Read More

Put the Power of Intelligent
Automation to Work Today

Sware was built to serve the unique, complex requirements around CSV for regulated systems. Leverage our intelligent validation automation platform and our deep compliance expertise to your benefit — reach out today and schedule a no-obligation, no-pressure session with one of our team members.We’re here to help you.