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Responding to the FDA Draft Guidance for Production and Quality System Software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

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.

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.

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. 

“Sware is a rare solutions provider that provides both the platform and the people needed to excel at validation, saving us time and money and making our lives considerably easier.”

– Director, Clinical and Development Systems, Biopharmaceutical Company

"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

"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 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.

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 today’s rapidly evolving life sciences landscape, treating validation as a series of isolated projects is no longer optimal. In this webinar hosted by Xtalks, our expert panel discusses the critical importance of treating validation as a core element of an organization’s quality management system (QMS).

Making the jump from CSV to CSA will require close collaboration between IT and Quality teams – and a solid understanding of role future technologies will play. Join our expert panel for an engaging webinar, hosted by Xtalks, to learn more about the key role collaboration, technology, and market forces will play in tomorrow's compliance landscape.

In this presentation at the 5th Annual GxP Cloud Compliance Summit, featured speaker Bryan Ennis, President, Sware, explores important topics that Quality and IT leaders should consider when developing an organizational path towards the use of AI within the GxP ecosystem.

As AI capabilities push into GxP regulated business functions, how can Quality and IT teams partner to ensure they are properly controlled? Join us as a panel of experts walks you through emerging practices for how Life Sciences companies can integrate AI-based solutions into GxP functions responsibly.

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.