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Why Digitalize Validation?

Sikich

Oct 31 2024

3 min read

Organizations operating in regulated sectors, such as life sciences, have stringent industry standards and regulations to meet—software validation can support this vital responsibility. Software validation can contribute to the quality, safety and reliability of your organization’s software products, ensuring the software meets defined requirements and functions correctly (reducing the likelihood of defects). Validating your software generates detailed records of development and testing validation activities, which makes it easier to demonstrate compliance during audits and reviews. It also allows future updates and changes to be streamlined.

Business leaders can actually cut costs when implementing a robust validation strategy—since it reduces the risk of defects, rework and potential legal issues.

And sure, paper and ink have served us well for decades—so why should companies move to this digital platform? Our experts provide our top reasons below:

The Benefits of Digitalizing Validation

Beyond reducing errors and manual time invested into validating your software, the efficiency of software validation allows businesses to speed up their workflows and deliver consistent outcomes in a reliable, uniform way.

Digitalizing validation also offers enhanced traceability—digital records provide a clear audit trail that simplifies tracking changes, decisions and compliance with regulations.

Fortunately, digital validation easily adapts to increasing validation demands without the need for extensive additional resources. It scales with your organization. As trusted as pen and paper are, there’s no real way to collaborate with others. Leveraging digital platforms facilitates better communication among teams, regardless of location.

How Can You Digitalize Validation?

There are plenty of strong tools on the market that allow businesses to digitalize their validation software. When considering your options, strive to find a tool specifically designed for validation in regulated industries so you can comply with standards such as FDA and ISO. Target a tool that centralizes your documentation and data, making it easier to manage and retrieve information when needed. And if there’s a bit of a learning curve on your team, find a digital tool with an accessible design, making it work for users across different levels of technical expertise.

Software validation is a necessary, important tool for life sciences organizations to leverage. Moving to a digital platform simplifies the process and enhances your company’s software. If you’re exploring tools and need to consider the best fit for your organization, or if you’d like to learn more about the benefits of digitalizing your validation, please contact our experts.

About Our Authors

Patrick Walsh is a solution architect in Sikich’s IT quality and compliance advisory group. He has over 20 years of quality and compliance experience in the pharma industry. In his role, Patrick leads the charge in optimizing computerized systems validation and compliance for life sciences companies.

Emily Boylan is a global quality assurance professional with nearly 20 years’ experience in project management, data integrity and analytics, and administration in the clinical research industry. She is responsible for the development and delivery of projects within specific standards.

This publication contains general information only and Sikich is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or any other professional advice or services. This publication is not a substitute for such professional advice or services, nor should you use it as a basis for any decision, action or omission that may affect you or your business. Before making any decision, taking any action or omitting an action that may affect you or your business, you should consult a qualified professional advisor. In addition, this publication may contain certain content generated by an artificial intelligence (AI) language model. You acknowledge that Sikich shall not be responsible for any loss sustained by you or any person who relies on this publication.

About the Author

Sikich

Sikich is a global company specializing in technology-enabled professional services. With more than 1,900 employees, Sikich draws on a diverse portfolio of technology solutions to deliver transformative digital strategies and is comprised of one of the largest CPA firms in the United States. From corporations and not-for-profits to state and local governments and federal agencies, Sikich clients utilize a broad spectrum of services* and products to help them improve performance and achieve long-term, strategic goals. *Securities offered through Sikich Corporate Finance LLC, member FINRA/SIPC. Investment advisory services offered through Sikich Financial, an SEC Registered Investment Advisor. 