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.
However, figuring out how to use a paperless validation system can be challenging. It requires thorough risk assessments to ensure the digital systems can provide the necessary data security and efficiency gains that would make the transition to paperless process validation worth it.
To get to the core of these sentiments, we spoke with multiple IT and quality professionals at life science organizations large and small. Our goal was to find out how compliance stewards view validation in the modern era, and what kind of future state they envision as they try to meet demands for growth.
Here’s what we learned.
Paperless validation is an electronic process for ensuring that equipment, software, procedures, and other processes comply with the strict regulatory compliance requirements in the life sciences industry imposed by FDA, EMA, WHO, and other regulatory bodies.
The rise of paperless validation software for life science companies has been a paradigm shift, dramatically reducing the amount of paper-based documentation while boosting efficiency and accuracy in the process.
With the help of a paperless validation system, organizations can:
We encountered repeatedly the theme that digital, paperless validation has moved from a “nice-to-have” to a mandatory capability. It’s a known fact that organizations that have moved away from paper spend less time and human resources validating a mountain of systems.
The terms “liberating” and “empowering” were often used to describe the transition from paper-based to paperless. Managing validation activities and documentation with paperless validation software offers speed and flexibility the life sciences industry has not experienced before.
Paperless validation systems help accelerate validation projects, reduce manual errors, and increase workforce productivity. Workflow automation ensures that electronic validation activities are efficient, highly consistent, and users adhere to quality processes. Improved visibility, version control, and traceability ensures integrity across the entire system management lifecycle.
Paperless validation offers several advantages:
At this point, organizations should ask themselves: is paperless validation alone sufficient to mitigate risk, future-proof our business, and realize value?
The answer: no. Modern validation solutions shouldn’t just digitize and organize paper assets. They should automate every aspect of the validation process. True workflow automation unifies and accelerates every aspect of software validation across all phases of the system lifecycle.
The right modern validation solution will increase efficiency dramatically, safeguard against serious risk, and ensures that organizations can accommodate a landslide of new validation requirements with relative ease.
Today, Res_Q from Sware is the only validation solution that fully automates CSV. Rather than rely on document templates and a folder structure, Res_Q automates the entire validation process, scales with ease, and builds risk assurance directly into workflows via digital standard operating procedures (SOPs). Res_Q’s end-to-end workflow automation accommodates any system, risk profile, and testing strategy, providing customers with the versatility needed to automate, unify, and accelerate all their validation processes.
To learn more about the Res_Q platform, visit https://www.sware.com/solutions/platform.