Ketryx for enterprises
Maximize efficiency and profitability
By automating the DHF, Ketryx frees teams to focus on building life-saving products rather than chasing down documentation. As a result, Ketryx customers bring more releases to market faster without adding resources or costs, maximizing profitability.
Streamline change management without compromising quality
According to the FDA, one of the most common reasons for an audit is not following SOPs. Because Ketryx enforces SOPs across all phases of the development cycle, our customers rarely see audits on this issue. Pre-release issues that could affect performance are identified and mitigated without compromising speed or safety. Teams easily isolate and trace interdependencies without combing through endless spreadsheets. Quality finds peace of mind with the creation of a defensible system with FDA-ready audit trails.
Optimize your existing investment
As an overlay, Ketryx doesn’t replace your existing QMS or dev tools—it connects them, eliminating error-prone copying and pasting from previous siloed systems. Ketryx traces all tasks, activities, and workflows throughout the product lifecycle, from design to post-launch, across different teams, departments, and systems.
Stay on top of regulatory guidance
Regulations will continue to change in critical areas like security and AI/ML. Ketryx makes it easy for you to stay ahead of new requirements with continuous releases, updates, and built-in guardrails that anticipate and automate compliance with new requirements.
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