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Sware TeamMay 1, 20243 min read

Automation: The Future of Paperless Validation in Life Sciences

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. 

 

What is Paperless Validation?

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: 

  • Reduce the risk of compliance violations by having a centralized system for adhering to the various regulations throughout the validation lifecycle. 
  • Enjoy cost savings by not having to worry about printing, storing, and handling documents while also streamlining internal and external audits. 
  • Enhance data integrity by having a more secure and auditable trail of data and better validation protocols. 
  • Improve data management through better access and standardized documentation practices. 
  • Decrease the time to market by increasing efficiency at various stages of the validation process.

 

Paperless Validation is now mandatory

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: 

  • Fewer Manual Tasks: Fully removing human activity from validation processes is impossible (and unwise), but reducing manual steps is essential. Manual work drains resources from other, higher-value projects, and increases the risk of human error, degrading risk assurance.  
  • Superior Risk Assurance: Validating hundreds or thousands of requirements requires flawless attention to detail. Lapses affect audit readiness and can lead to rework, project delays, and at worst, financial penalties. Integrating risk assessment into multiple levels of an organization’s validation process creates a critical safeguard and focuses efforts on requirements with a demonstrable risk impact.  
  • Inherent Scalability: Automated workflows can scale, adapting seamlessly to changing business requirements. As organizations grow, automated systems can evolve to accommodate increased volumes of data and transactions, supporting business expansion without compromising accuracy. 

 

Advantages of Paperless Validation: Fewer Manual Tasks, Superior Risk Assurance, and Inherent Scalability

 

Choosing the right paperless validation solution

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.

 

Embrace the future of paperless with Res_Q

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 

 


 

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