How to Transition to
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.Read the Free Paper Here
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Responding to the FDA Draft Guidance for Production and Quality System Software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.
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.
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, 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.
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.
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.