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Best Practices for Software Validation in Life Sciences 

Software validation, a standard practice in life sciences quality and compliance, has become even more critically important over the last few years. The pandemic has spurred rapid innovation and changes within the life sciences space. With the boost in innovation and continued advancements in systems and solutions, businesses are increasingly looking to validated software to help develop their products, respond to the demands for technological solutions, and drive growth and continuous improvement. Not only can software development help an organization meet its mission-critical and unique business goals, but it can also serve as a competitive advantage. In a growing and increasingly competitive industry, investing in the right software to help realize your business’ short- and long-term goals is absolutely critical. 

Proper validation of any software is also critical. Your next big product or breakthrough means little without validation of its quality and efficacy. Validation – also referred to as assurance – provides a strategy to ensure that processes supported by custom software run consistently as intended and comply with industry standards. Proper software validation can also protect revenue streams, allowing companies to scale up their operations, and promote collaboration that helps a company meet its business goals.  

Tips for Software Validation Success

As companies make a shift toward implementing software systems to better adapt to and compete in a constantly evolving and growing industry, prioritizing validation for those systems is essential. Here are five considerations for successful validation: 

  • Begin with good documentation: This means starting with a solid validation master plan. Any system that requires a detailed inventory of deliverables and risk assessment for testing approaches will require a validation master plan. Given the wide scope and levels of complexity validation projects can have, each project needs to be appropriately assessed to determine the validation tasks and their dependencies, scheduling, and resources. 
  • Take a risk-based approach: For software validation plans, a risk-based approach which focuses on high-risk areas of the system is recommended. This is a valuable use of time and resources that serves to reduce the testing efforts on low-risk areas while simultaneously demonstrating that the system performs as intended. 
  • Prepare and train your validation team: Ultimately, your people will be the driving force behind any successful validation initiative. As such, it’s beneficial to perform a skills audit to make sure that the validation team has the pertinent vocational competencies and current industry skills relevant to the software being validated. Where skills are lacking, invest in training, which will improve the knowledge and skills of the team and increase productivity. 
  • Engage industry experts: Having your validation team working with experts who need little runway to get the project up and running will not only save you time, but it will also spur knowledge transfer and on-time delivery. This is especially useful for small-scale to medium-scale organizations. The experience that industry experts can bring to the validation process is invaluable, as they can advise and offer feedback on how to handle specific tasks and manage the process. 
  • Encourage and welcome collaboration: Collaboration in validation can increase confidence in the regulatory compliance of the company as well as those that it serves. 


Although the process for software validation requires significant time and resources, its benefits will bring value to your organization. Proper software validation can provide your business with: 

  • A formalized and well-documented process that follows industry standards of regulatory compliance, thereby enhancing system value and product quality. 
  • Assurance that the system and processes operate as intended. 
  • Credibility and compliance with the FDA  
    • A software validation failure during an FDA inspection may result in the issuing of a Form 483, which means FDA investigators have deemed objectionable conditions. This setback can result in serious business disruptions, possible criminal prosecution, and damage to your brand.  
  • A way to expose flaws in the process design and in the system, encouraging collaboration across the board – from vendors to designers to end users – and bringing about business alignment. 

Our team at Clarkston has experience in developing comprehensive assurance strategies and ensuring validation success – let us know how we can help your company.  

To learn more about validating software in the life sciences industry, fill out the form below to download a quick reference infographic:


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Contributions from Lloyd Dzinotyiwei and David Patterson

Tags: Validation Strategy & Services