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Explore Featured Resources

Explore resources and case studies from real clients. See how our customers were rescued from validation debt in their organizations.

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WHITEPAPERThe Future of Life Sciences Validation is Here: Are You Ready?

The future of life sciences validation and compliance is not so far away. Already, we are seeing life sciences companies rush to integrate AI where possible, while at the same time striving to manage risk with fewer human and material resources available.

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Case Study - Nuvolo
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CASE STUDYTo Deliver a Modern, Fully Scalable Validation and GxP Compliance Solution to Nuvolo’s Life Sciences Customers

"Today most organizations are using pen and paper which may as well be a stone and chisel.  Our system is completely digitally mapped.  Sware provided invaluable support, bringing deep industry knowledge, experience and connections to our project."

– Jason Siegrist, Chief Information Security Officer, Nuvolo

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Case Study - Biotechnology Company
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CASE STUDYReduce Validation Bottlenecks, Improve Efficiency and Mitigate Risk Even as Required Validation Volume Grew

"Res_Q has saved us time and resources, reducing validation time by 30-40%. I wholeheartedly recommend Res_Q to fellow industry professionals seeking to enhance their validation processes."

– Sr. Director, IT Business Partner, GxP Systems

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Case Study - Pharmaceutical Research Company
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CASE STUDYAn Increasing Burden to Maintain a State of Compliance to Accommodate Growth

"We have shifted from CSV to CSA and now succeed with less documentation and more critical thinking. The difference pre- and post-  Res_Q is simply night and day, we have accelerated our validation time by 75%!"

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Case Study - Molecular Medicine Company
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CASE STUDYExisting Computer System Validation Couldn't Ensure GxP Across the Digital Ecosystem

"The time to execute validation workstreams went from days to hours with the implementation of Res_Q. We now have a proactive posture when it comes to cost and risk management. Res_Q is now a fundamental part of our bigger technology and compliance picture."

– Senior Director, Development Informatics

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Ebook - Rescue Your Organization from Validation Debt
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EBOOKRescue Your Organization from Validation Debt

"We have 400 test scripts that we have to run four times annually for a single enterprise system. That equates to 4,000-man hours per year for the sole purpose of verifying the system works the same as before. This is not sustainable."

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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.

Article - MasterControl, Validation 4.0: How to Avoid Document-Centric CSV Traffic Jams
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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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Article - Three Ways Life Sciences CIOs Can Prioritize Validation 4.0, from 'Forbes'
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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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Article - Advancing the Transition to Computer Software Assurance
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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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Article - Transitioning to Validation 4.0: A Roadmap for the Journey, from 'MasterControl'
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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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Article - The Business Imperative of Validation as a Forethought in Life Sciences, from 'Forbes'
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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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Article - Lessons Learned: Leveraging Pandemic Pandemonium for a Better Future, from 'the Medicine Maker'
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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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Article - Archiving and Validation: Leading with Digital in Life Sciences, from 'Arkivum'
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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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Blog - Automation: The Future of Paperless Validation in Life Sciences
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BLOGAutomation: The Future of Paperless Validation in Life Sciences

In a world that’s embracing digital transformation, the shift from traditional, paper-based validation to a modern, technology-centric approach comes with high expectations – stakeholders expect to see dramatic improvements in processes, time, and resources.

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Blog - Building Risk Assurance into Life Sciences
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BLOGBuilding Risk Assurance into Life Sciences Computer System Validation with Automated Workflows

Deploy a risk assessment strategy to prioritize high vs. low tasks and stay current with system releases as you adopt more technology. Find out how.

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Blog - Take Charge of Validation Debt in your Life Sciences Organization
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BLOGTake Charge of Validation Debt in your Life Sciences Organization

Mounting validation debt is costing life sciences companies time and money. Learn how to recognize and resolve it with a clear, actionable strategy.

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Blog - What Is Computer System Validation and Why Is It Important
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BLOGWhat Is Computer System Validation and Why Is It Important?

Computer System Validation (CSV) is a process used in the pharmaceutical, healthcare, and other regulated industries to ensure that computer systems consistently meet their predefined specifications and fulfill their intended purpose.

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Blog - What is Process Validation: Pharmaceuticals Validation
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BLOGWhat is Process Validation: Pharmaceutical Industry

The Good Practice (GxP) guidelines serve as a framework for numerous pharmaceutical validation processes and the corresponding documentation. These processes include computer validation, equipment validation, facilities validation, and process validation.

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Blog - What is GxP Compliance in the Pharmaceutical Industry?
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BLOGWhat is GxP Compliance in the Pharmaceutical Industry?

The pharmaceutical industry has a set of guidelines and regulations that ensure the quality, safety, and efficacy of products in the life sciences industry. These are referred to as Good Practices, abbreviated as GxP.

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Blog - 21 CFR Part 11 Basics: Connecting the Dots From Regulation to Compliance in the Life Sciences Industry
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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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Blog - Res_Q and AI: Modicus Prime Image Analysis for Quality Assurance
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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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Blog - CSA vs CSV: What a Difference One Letter Can Make!
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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
Blog - Automating Software Validation:
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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
Blog - Life Sciences: Regulatory Issues on Your Radar Screen
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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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Blog - Embracing Equity Naturally: Lessons Learned from My Dad
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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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Blog - Digital Validation: A Technology Solution You’ll Sware By
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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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SWR_Resources_Nuvolo_Case-Study
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CASE STUDYNuvolo: A Sware Technology Partner

"Today most organizations are using pen and paper which may as well be a stone and chisel.  Our system is completely digitally mapped.  Sware provided invaluable support, bringing deep industry knowledge, experience and connections to our project."

– Jason Siegrist, Chief Information Security Officer, Nuvolo

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Case Study - Biotechnology Company
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CASE STUDYBiotechnology Company

"Res_Q has saved us time and resources, reducing validation time by 30-40%. I wholeheartedly recommend Res_Q to fellow industry professionals seeking to enhance their validation processes."

– Sr. Director, IT Business Partner, GxP Systems

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Case Study - Pharma Research Company
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CASE STUDYPharmaceutical Research Company

"We have shifted from CSV to CSA and now succeed with less documentation and more critical thinking. The difference pre- and post-  Res_Q is simply night and day, we have accelerated our validation time by 75%!"

Read More
Case Study - Molecular Medicine Company
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CASE STUDYMolecular Medicine Company

"The time to execute validation workstreams went from days to hours with the implementation of Res_Q. We now have a proactive posture when it comes to cost and risk management. Res_Q is now a fundamental part of our bigger technology and compliance picture."

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Ebook - Rescue your Organization from Validation Debt
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EBOOKRescue your Organization from Validation Debt

Manual computer software validation (CSV) processes cost life sciences organizations up to 30% in additional project budget while degrading risk assurance. As companies struggle to keep up with a surge of app and software integrations, they incur validation debt: the mounting cost of stretched resources, blanket testing, and missed GxP requirements.

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Whitepaper - The Future of Life Sciences Validation
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WHITEPAPERThe Future of Life Sciences Validation is Here: Are You Ready?

The future of life sciences validation and compliance is not so far away. Already, we are seeing life sciences companies rush to integrate AI where possible, while at the same time striving to manage risk with fewer human and material resources available.

Read More
Whitepaper - How to Transition to Validation 4.0
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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.

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Whitepaper - Moving Beyond Paper-based Validation
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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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Webinar_RAPS_Risk-Assessment-Life-Sciences_Full
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WEBINARRisk Assessment in the Life Sciences

In this webcast presented by RAPS, quality expert Blake Jensen (Founder, Principal Consultant, B3 Quality Consulting) discusses risk assessment and risk management approaches that support growth more efficiently, as well as the upstream and downstream impacts of risk assessment.

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Webinar - Utilizing an Automated Validation Platform to Ensure Compliance with Greater Efficiency and Consistency
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WEBINARUtilizing an Automated Validation Platform to Ensure Compliance with Greater Efficiency and Consistency

In this webcast presented by RAPS, three life sciences companies share the challenges they were facing, their experiences implementing a SaaS based Computer Systems Validation (CSV) platform, and the business value achieved.

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Webinar - Pharma 4.0 and Beyond: Getting to the Future State Faster
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WEBINARPharma 4.0 and Beyond: Getting to the Future State Faster

In this webcast presented by RAPS, Bryan Ennis and David Hall Rode explore the future state of technology across pharmaceutical manufacturing and the challenges companies will face.

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Webinar - Managing Change in AI-Based Systems
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WEBINARManaging 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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Peer Panel - Digital Validation: Bringing Together Quality & IT
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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 Chat - How to Transition to Validation 4.0 for SMBs
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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 Chat - The Future Trends of Digital Validation
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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 Sheet - Res_Q Overview
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ONE-SHEETRes_Q Overview

Rescue your organization from validation debt with Res_Q – the validation solution that automates, unifies, and accelerates your success.

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Press Release - Sware Partners with Verista
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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 Release - Sware Partners with Benchling, Sware and Benchling logo with a horizontal dividing line
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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 Release - BTR Rebrands to Sware
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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
Press Release - Sware Raises $15M in Series A Round, with green bar/line graph
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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.