By Sware Team
Life science software validation was a problem that you could control in the past. One or two releases or updates per year used to be manageable, with a predictable amount of IT and Quality resources able to accommodate your needs.
But with the adoption of agile methodology, software companies are generating new features and functions at a higher level of frequency, increasing the pace of SaaS releases, and compounding validation burdens significantly. Evolving compliance regulations (such as Computer Systems Assurance, or CSA), and technology innovations (such as the adoption of AI/ML) have combined with emerging business realities. These realities, such as leaner IT and Quality departments and the ongoing stream of mergers and acquisitions, further increase the software validation challenges life sciences companies face. Companies are struggling to keep up with all these challenges and falling behind on previously unaddressed validation projects, saddling them with an unprecedented amount of validation debt. This situation expressly required a new approach to manage the validation efforts to ensure compliance with all the current laws and regulations.
Validation Debt (n.) - the accumulation of validation-related imperatives, costs, and bottlenecks an organization faces over its technological lifetime in a heavily regulated industry.
Validation debt adds significant complexity to life sciences compliance, costing companies valuable time, money, and human resources. Outdated validation approaches that use paper-based processes and resource-intensive applications place immense stress on IT and quality leaders, who are now expected to be experts on dozens of clinical and manufacturing systems, regulatory mandates, and personnel management. Ensuring that every person involved has access to specific information about validation procedures becomes critical, as it directly impacts the ability to maintain compliance and streamline operations. The sales pitch to businesses to buy SaaS software usually includes the promise that “it’s easy to be in the cloud”; i.e., that cloud solutions offer easier adoption and maintenance. But in the case of software that needs to be validated, this simply isn’t the case.
As life sciences companies progress through their clinical and commercial lifecycle, new and complex technologies are adopted, so validation debt continues to compound.
Day-to-day costs aside, inadequate validation methods have serious consequences. Validation quality and documentation gaps expose audit liability, and organizations owe it to their stakeholders to conduct thorough verification of their validation information to prevent these debts from compromising the integrity of their operations. Regulatory red flags can lead to launch delays and massive budget overages, jeopardizing the delivery of new therapies and punishing private and public stakeholders. For smaller pharmaceutical and biotech companies, this isn’t just a bump in the road: it’s an existential threat.
Recognizing the amount of debt tied to validation challenges is the first step toward strategizing on how to stop validation debt. However, mitigating validation debt takes time, strategy, and cross-functional collaboration. Regarding how to reduce validation debt, here are practical steps that organizations can take to draw down their debt, reclaim valuable resources, and mitigate risk:
Build Your Team
Involve Your Vendors
Integrate All Systems to Reach a Debt-Free, Real-Time State of Compliance
One size does not fit all. As you review your validated status, systems will have varying levels of debt and require different levels of validation remediation.
Futureproof
As validation debt compiles, IT and quality leaders face immense pressure to do more with less. Having a sound strategy and actionable goals in place positions your organization for near- and long-term success.
Today, increasingly sophisticated validation solutions offer a seamless, intuitive way to bridge the strategy and actions needed to improve validation processes and eliminate costly validation debt. Res_Q by Sware is purpose-built to address validation challenges across the enterprise. Res_Q automates your validation systems and processes, accelerates validation time by up to 80%, all while ensuring rigorous audit readiness.