We help life sciences companies embrace automation to navigate the complexities of traditional Validation and Verification (V&V) processes.
V&V in life sciences
Stringent regulatory rigor is crucial to maintaining safety and efficiency in life sciences—a high-stakes industry with several real-world implications.
V&V processes are crucial to regulatory requirements and organizational practices. Traditionally, these processes have largely been document-driven, often leaving less time for the critical task of testing. As the industry pivots toward more fast-paced, automated digital models, adopting efficient solutions like CSA will reduce duplication, ensuring production efficiency and reliable results. While verification ensures the design requirements are fulfilled, validation proves that the product works as intended in the real world. To mitigate risks, V&V ensures regulatory compliance, robust product quality, and patient safety. The problem, however, lies in its traditional approach that deals with computerized system certifications. These are often bogged down by excessive documentation that eats up resources and hinders the testing phase’s overall effectiveness.
Challenges in traditional V&V processes
Documentation consumes as much as 80% of the total effort, leaving only 20% for actual testing.
Some of the key challenges faced by enterprises during the various phases of V&V are as follows:
- Requirement gathering: Ambiguity in functional and non-functional requirements arises due to multiple stakeholders and changing project parameters.
- Documentation: Comprehensive documentation can be burdensome and time-consuming.
- Testing: Proper evidence of testing is vital for regulatory compliance but difficult to manage.
- Design history file: Maintaining a comprehensive, up-to-date design history file is complicated.
- Risk assessment: Risk mitigation requires careful planning, and manual processes are prone to error.
- Test automation: Automating the testing phase is key to speeding up the process but integrating it with existing systems is complex.
Best practices for an efficient V&V process
Optimize traditional methods to ensure compliance, reduce risk, and enhance efficiency.
- Risk-based validation: Focus validation efforts on high-risk systems that directly impact product quality or patient safety.
- Life cycle approach: Validate systems at implementation and continuously monitor them throughout their operational life.
- Clear documentation: Justify validation efforts with clear, concise documentation that explains risk classifications.
- Data integrity and security: Ensure data is accurate, secure, and auditable, especially when adhering to electronic record and signature requirements.
Computerized Systems Assurance (CSA) streamlines validation by concentrating efforts on critical areas. Instead of applying the same validation rules across systems, CSA tailors validation efforts based on a system’s importance and risk profile.
How Brillio’s CSA solution automates the V&V process
Imagine a world where the complexities of the V&V process are simplified and streamlined with intelligent automation.
Our life sciences IT solution brings this vision to life, ensuring efficiency, accuracy, and foresight with the following seven automation features:
- Validation automation: Create validation plans, execution summary reports, and test protocols with GenAI, pulling key information from testing reports to streamline documentation.
- Traceability management: Link requirements and test protocols even as requirements evolve by integrating seamlessly with Application Lifecycle Management (ALM) and Validation Lifecycle Management (VLM) tools to generate a Real-time Requirements Traceability Matrix (RTM), thereby ensuring continuous alignment.
- Risk-based testing: Assess risks early with our predictive machine learning model to automatically generate test plans and prioritize critical test cases first based on risk level.
- Intelligent testing management: Generate test scripts that align with functional requirements and predict potential failures, empowering teams to solve issues proactively.
- Change control and impact analysis: Evaluate the impact of system updates or requirement changes, adjust test sets, and optimize regression testing to ensure comprehensive assessments.
- Compliance and regulatory alignment: Ensure regulatory rigor with automated adherence checks to standards like FDA 21, CFR Part 11, and ISO 13485, accelerating regulatory approvals.
- Review and collaboration: Automate document validation and asset reviews, trigger updates or retirements as needed. Get actionable intelligence to help teams identify failure-prone areas and track progress effectively.
Our solution automates all stages of the V&V journey, from documentation to testing, ensuring that the validation process is streamlined, proactive, and future-proof. In a world of constantly changing regulations and complex systems, intelligent automation isn’t just a luxury but a necessity. By embracing automation, companies can improve efficiency and compliance and ensure safer and more reliable products.
