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Why Paperless Validation Is Important
To address the modern challenges, we have explored earlier and emerging opportunities (such as the integration with automatic testing tools) in the life sciences industry:, digital validation tools are not only necessary but crucial in transforming our approach to validation from just a documenting exercise into a comprehensive quality assurance process that aligns with today's regulatory and industry expectations. Life sciences businesses are increasingly adopting paperless validation to not only overcome the pitfalls of traditional validation but also leverage technology in the validation process to bring higher quality standards saving time and money. Regulatory bodies such as the FDA have recognized the value of this approach, with the FDA's Computer Software Assurance draft guidance even encouraging life sciences companies to leverage supplier documentation and focus on critical aspects instead of exhaustive documentation of non-GxP elements.
Key Insights from Our Experience
Shifting from a traditional system that regulated companies have been accustomed to and used for ages to a new one is never easy; however, from our experience working with leading life sciences organizations, once the transition is complete, employees experienced a significant improvement in workflow efficiency, better traceability, and long-term system reliability. They quickly realized the benefits of reduced rework, improved compliance with evolving regulatory standards, and, most importantly, a more streamlined and effective validation process. The paperless approach to validation did not only speed up their workflow, it allowed the organization to direct all their focus on quality, a key aspect of the life sciences, instead of cumbersome documentation. While quality is often seen as an afterthought by some in the industry, our 26+ years in the industry have taught us that quality is a vital component of life sciences production and manufacturing that must be integrated from the start to reduce the need for workarounds later on.
Why You Should Consider Going Paperless
The shift to paperless validation is a strategic move necessary for modern life sciences companies to boost their efficiency and continue aligning with constantly evolving regulatory demands. The FDA's draft guidance on Computer Software Assurance and ISPE's GAMP 5 Second Edition both signal a shift to agile and risk-based validation methodologies, a clear indication for life sciences organizations to start embracing digital tools for improved efficiency, accuracy, and compliance. Our in-depth analysis explores the transition from the paper-based validation methods that have been used for decades to modern digital tools, covering everything from compliance with 21 CFR Part 11, EU Annex 11, and global standards in GxP environments to manufacturing, as well as key essentials such as the long-term benefits of switching to paperless validation. Still in doubt or want to learn more? Download our comprehensive in depth analysis to gain deeper insights into best practices and key implementation steps, and see how PQE Group is helping leading life sciences companies leverage paperless validation to drive innovation and efficiency while ensuring regulatory compliance in the real world.
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