Santa Clara, March 21, 2023: ValGenesis, the market leader in enterprise validation lifecycle management systems (VLMS), today announced the release of ValGenesis Design Manager, a new module within VLMS 4.2 that is ready for computer software assurance (CSA) out of the box. As a new module within VLMS 4.2, Design Manager enables any company to develop risk-based requirements and apply critical thinking to validation processes.
FDA guidance on CSA, updated ICH Q9, and GAMP 5 E2 advocate for critical thinking upfront and the least burdensome, risk-based approach to validation. Companies wishing to transition away from document-heavy computer system validation (CSV) are eager to employ technology that supports this transition. This is nearly impossible with validation software solutions available in the market.
Design Manager is the only purpose-built validation application that applies risk-based requirements upfront and enables scripted and ad hoc testing to reduce unnecessary testing and documentation by as much as 60%. This lean validation approach is transformative for teams looking to achieve the highest productivity levels.
Furthermore, life sciences companies can apply unlimited test types (ad hoc, exploratory, unscripted, positive, negative, performance, security, boundary, scripted, white box, black box) and associated frameworks based on risk outcome. The tool also auto-populates protocols with test results from automated test execution with the possibility to integrate third-party test automation software.
As Design Manager is built into ValGenesis VLMS, customers can even run traditional CSV processes alongside CSA at the same time.
Supporting Agile Methodology
Design Manager also enables customers to align validation processes to agile methodology, supporting backlog, sprint, testing, and release management. This iterative approach promotes ad hoc and scripted testing to break free from linear, rigid testing and development, dramatically boosting flexibility and time efficiency.
The benefits of agile are fully realized with the Design Manager. Teams can link requirements to user stories and tests, add requirements to the backlog at any time, change requirements as needed and track those changes in an audit trail, and even apply flexible versioning at the requirements level to match your numbering scheme.
Aligning with SDLC
Medical software developers and vendors, developers of medical devices with software components, ‘software as a medical device’ companies, and any life sciences company with a mature SDLC process have long struggled with dual systems for testing and validation.
Design Manager unifies validation data into a single source of truth. Teams can reuse content and reduce effort by 80%, enforce data integrity principles with compliant electronic signatures, and produce evidence of following SOPs with technology controls that adhere to processes.
Built for Modern Validation
ValGenesis VLMS with Design Manager is a modern, purpose-built, risk-based, data-driven solution that helps life sciences companies comply with the new CSA guidance. It supports the testing strategies championed by CSA. The system not only “right sizes” validation efforts but also offers the maximum benefits of agile software development, critical thinking, and smart validation in a 100% paperless system.
“The imperative for digitization and automation has never been more urgent for life sciences companies intending to keep pace with ever-changing regulations,” says Dr. Siva Samy, CEO at ValGenesis. “Our purpose-built solution is designed to enable the application of critical thinking upfront, helping life sciences companies to build a risk-based approach and culture of quality in line with the most stringent regulatory requirements.”
“Ideally suited for any GxP application or SDLC process, our solution brings risk assessment at the requirement level, enabling customer-centric agile requirements management with the backlog, sprint, testing, and release management,” says Mike Hicks, CTO at ValGenesis. “This unifies validation and development systems and promotes iterative development and cross-functional collaboration – a competitive differentiator for companies making the Pharma 4.0 journey.”