Enforce process control
Built-in guardrails reduce risk
Ketryx built-in guardrails enforce your rules and guidelines, automatically stopping any product from progressing unless it is compliant.
Build safer software
Eliminate the human error that comes from manually re-entering data and copy/pasting it across different systems. Ketryx enables you to connect ALL systems across your department and enterprise in real-time automatically.
Gain peace of mind with FDA-ready documentation
Preparing for audits requires an up-to-date traceability matrix, among other documentation, to prove your systems are defensible. Ketryx overlays your existing QMS, workflows and dev tools to ensure traceability isn’t an afterthought by automatically compiling FDA-ready documentation from all your systems. Designed by former FDA talent and other regulated industry experts, Ketryx's built-in intelligence will keep your documentation audit-ready.
Keep up with regulatory guidance
Cloud adoption is driving new FDA guidance, and the burden of maintaining cybersecurity is on manufacturers. Ketryx streamlines risk management with easy patch implementation and automatic generation of new version documents, providing full support for regulatory requirements with no disruption to your team's daily workflow.
Quality isn’t just a department – you’re the heart of the entire product lifecycle. Without Quality nothing else that happens in the product life cycle matters. Ketryx infuses quality into every stage of the product life cycle, ensuring quality at the source and compliance throughout the process.
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