Blog Post


The Benefits of Life Sciences Validation Software Solutions 

The Benefits of Life Sciences Validation Software Solutions

Life sciences companies need help to keep up with business complexity and rapid technological change. They need to validate new software, revalidate existing systems during upgrades, and keep all their documentation in a consistent, accessible state.

A validation solution enables Life Sciences organizations to eliminate manual work and make their processes more efficient. Here are some of the benefits you’ll see by implementing our validation software:

Reduced Risk of Compliance Violations

Handling business complexity and rapid technological change is a significant challenge for life sciences, biotech, medical device, and pharmaceutical companies. These companies must manage various complex production processes, work with advanced digital technologies like artificial intelligence, chart their strategy with new manufacturing processes and techniques, navigate the fallout from healthcare industry reform, take on global competition, shorten time to market, and meet regulatory compliance guidelines.

Quality management systems (QMS) software manages many of these tasks. Life science organizations must typically validate their QMS software to ensure it functions as initially designed. However, manually validating software can be very difficult and expensive. Choosing pre-validated life science validation software solutions reduces this burden and allows companies to implement and use their new technology more quickly.

For life science companies, it is critical to validate that the software used to maintain 21 CFR Part 11 records has accuracy, reliability, integrity, availability, and authenticity. With the pace of innovation in the life sciences industry, it’s also imperative that these apps can be updated and released constantly without impacting the ability to meet compliance requirements. Unfortunately, manual validation tools cannot handle these rapid changes and can create an impossible backlog of apps needing review.

Increased Data Integrity

When a company is working with life-saving products, it’s vital to have dependable data integrity practices. Incorrect information can have disastrous consequences, from slowing market access to halting production processes to costly fines. However, with the right digital tools, life sciences companies can improve data accuracy and accessibility across their entire enterprise.

Traditional paper-based processes, which rely heavily on procedure controls and the honesty and diligence of people to complete and execute them, leave life sciences companies vulnerable to a wide range of problems that affect data integrity. With a pre-validated EDMS system designed to take IQ, OQ, and PQ tasks off the plate, companies can save time and resources while significantly improving their overall data integrity and compliance.

Using a validation-as-a-service platform that ensures that all processes comply with FDA regulations, including 21 CFR Part 11, eliminates much of the worry of managing complex life sciences software applications. Moreover, it also helps regulated companies avoid the risk of data gaps that can result in the need for extensive troubleshooting and re-validation of applications.

The good news is that the life science software industry is aware of these challenges and making significant strides towards lower effort, FDA-accepted validations. With that in mind, companies must prioritize validation support when evaluating potential solutions vendors.

Automated Document Management

For Life Sciences companies, the challenge is real. They must keep up with business complexity, handle rapid technological changes, deal with new manufacturing processes and techniques, understand the fallout from healthcare industry reform, and take on global competition. They must make intelligent, data-based decisions and provide their customers with high-quality products and services.

For many life sciences companies, managing documentation for their 21 CFR Part 11 compliance efforts is the biggest issue. This can be a significant burden that negatively impacts plant safety, financial efficiency, and operational excellence. It can be challenging to track many documents, and a single mistake could jeopardize a company’s ability to maintain compliance with regulatory bodies.

A solution is available. A cloud-based EDMS with validation-as-a-service can alleviate some of the workload of managing these documents. A system that can manage and maintain records – and their metadata – on an ongoing basis helps reduce risk, increase accuracy, and enhance data integrity.

To achieve this, life sciences companies need a digital solution ready to be validated, enforces compliance, and allows for standardization across the enterprise. That solution is a paperless Validation Lifecycle Management System (VLMS) that empowers life science companies to meet the demands of the modern business landscape. It combines a best-in-class platform with years of Life Sciences industry experience to deliver a fully 21 CFR Part 11 compliant solution designed to help companies scale and adapt.

Increased Efficiency

In a highly competitive industry like Life Sciences, every advantage counts in getting your products and innovations into the market faster. That’s why it’s so crucial for Life Sciences leaders to identify and adopt an integrated Quality Management System (QMS) with validation-as-a-service.

Traditional computer systems validation (CSV) protocols could be more efficient and leverage the critical thinking-based benefits of software assurance. They often involve massive amounts of tedious manual testing and documentation. Investing in a validation-as-a-service platform removes the burden of CSV from your team, freeing them up to focus on other critical projects like document management, project oversight, and more.

For example, a QMS solution with validation-as-a-service capabilities can provide automated validation scripts that run against the entire application portfolio and deliver IQ, OQ, and PQ system tests at the click of a button. This eliminates the need for life sciences companies to perform complex and time-consuming manual re-testing after each software upgrade, which can be challenging to keep up with as apps are constantly updated.

As a result, implementing continuous validation allows life sciences companies to unlock the full potential of their adopted technology with the peace of mind that they’re compliant with GxP requirements. It also ensures that the underlying infrastructure of a cloud-based app stays continuously validated, which mitigates the risk of future upgrades not being adequately tested or supported.

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