Quality Assurance and Regulatory Affairs
Build safe, compliant software
Enforce your QMS procedures, prevent process deviation, and ensure your software is audit-ready 100% of the time throughout the SDLC.
Quality leaders face mission-critical challenges that have become so complex, they are inhuman to manage.
Ensuring patient safety, preventing software errors, preparing for audits, and maintaining up-to-date documentation – all while managing risks across the SDLC – is daunting. Quality leaders use Ketryx to mitigate these challenges.
Prevent process deviation
Ketryx built-in guardrails enforce your rules and guidelines, automatically stopping any product from progressing unless it is compliant.
Ensure data consistency
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
Download Traceability e-bookPreparing 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 DevTools 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
Watch FDA OTS Guidance WebinarCloud 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.
Get started building software in minutes, not months.
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