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Enforce process control

Ensure your team is following SOPs exactly as you've defined them with real-time visibility into all transactions across ALL systems in your environment.

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.

Download Traceability e-book

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.

View latest FDA Guidance

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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