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The life sciences industry faces immense pressure to improve quality and manufacturing intelligence, stay in regulatory compliance, and drive business growth. Streamlining processes to make them paperless and faster helps companies meet these goals.
Validating a computer system is critical in ensuring it meets federally mandated regulations. It can also save companies time, money, and operational risk.
Automated Validation Scripts
Life sciences businesses must comply with FDA regulations, which mandate that all processes and equipment be validated. This includes software, which must be validated to ensure it functions as intended and produces quality results. The validation process requires a detailed set of procedures that must be established, documented, and maintained but can also be costly.
To validate software, what is a life science program must first test the system by simulating user actions and verifying that the results match expected outcomes. This is often referred to as writing test scripts. Test scripts must be written for each interface element and verified for each step in the system, which can be a significant undertaking. Using automated testing tools makes the process much more cost-effective and allows faster retests when updates or upgrades occur.
Many life sciences companies choose to validate a software solution as it is being used. This enables them to eliminate delays in implementing changes, reduce the risk of compliance issues and increase overall efficiency. The ability to change the system as they are being used is vital for life sciences companies that must quickly adapt to changing market conditions and regulatory demands.
Regulatory Compliance
Regulatory compliance issues are significant factors in life science organizations’ inability to use digital software solutions. Following industry compliance standards is not only critical for data protection but it’s also required to avoid costly fines for failing to follow the necessary rules.
As a result, life sciences companies are subject to stricter regulations than most other businesses. This is why they need to validate all their software systems according to 21 CFR Part 11 of FDA regulations. This involves planning, verification, testing, traceability, and configuration management to ensure that all systems meet requirements and are inspection-ready at any time.
Unfortunately, validation is a time-consuming process that requires significant resources. These resources are a company’s most valuable assets and must be put to the best use possible. Unfortunately, this often means that life sciences companies must choose between implementing new technology and validating existing systems.
Thankfully, vendors that understand the importance of reducing validation efforts are making significant strides in this area. This increases overall efficiencies, cuts documentation cycle times, improves cross-site collaboration, and boosts accountability. This is an excellent way for life sciences companies to leverage the benefits of a fully integrated paperless system and unlock the full potential of their adopted software.
Enhanced Efficiency
Many life sciences teams need help with the juggling act of multiple software tools. This is inefficient and leads to poor data quality, slower processes, and less-than-optimal utilization of a company’s most valuable asset: people. When people struggle with manual processes and navigating multiple software systems, they cannot focus on what indeed requires their human touch: research, testing, analysis, critical thinking, and problem-solving.
With the advent of new, digital-first technology that allows business leaders to automate and optimize much of the work previously carried out by their people, many life science businesses are embracing this opportunity to streamline their processes, improve productivity and reduce cost. However, consider how this shift from paper-based to digital processes might impact your life sciences validation process.
Any software that touches a regulated process must be validated following 21 CFR Part 11. To validate their software, life science businesses must prove the software enforces consistent processes outlined by the business and contains features like timestamps, user access logs, role-based permissions, and more.
Many software vendors understand the challenges of validating their software and are working to lower the effort required to validate their products while ensuring compliance with FDA regulations. These vendor advances can significantly reduce your life sciences validation project’s timeline and increase its effectiveness with the right turnkey validation system.
Reduced Risk
Biotech leaders can only afford efficient systems or processes in a fast-paced industry that strives to develop faster, safer, and more effective medical treatments for the patients who need them. Unfortunately, that often happens when companies need to implement the right software solutions.
The FDA requires that any software that touches regulated data must be validated. This is known as computer system validation (CSV). CSV is a complex process that requires extensive testing, documentation, and review to ensure that the software works as intended, much like a financial audit verifies accounting records.
Life science businesses often work with a third-party validation firm to validate their software systems, and they must revalidate the software each time it’s modified. This is costly and prevents life sciences companies from maximizing the value of their investments in their IT infrastructure.
Choosing a validation-ready solution with comprehensive documentation can reduce the cost of these projects and make them far more efficient in terms of both timelines and effort. Many vendors claim life science expertise, but an excellent way to test that claim is to see whether they provide pre-built validation documentation. If they don’t, that’s a red flag that the vendor is not prepared to handle the rigorous compliance requirements of life sciences organizations.
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