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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.

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.

Responding to the FDA Draft Guidance for Production and Quality System Software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

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

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

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

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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. 

"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

"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%!"

"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."

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.

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.

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.

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.

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.

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.

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.

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.

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. 

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.

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

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

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. 

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

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.

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.

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.