Gain 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.

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Built-in Guardrails Reduce Risk

Ketryx built-in guardrails enforce your rules and guidelines, automatically stopping any product from progressing unless it is compliant and transforming any developer into a regulated developer

Build Safer Software

Eliminate the possibility of human error that comes across manually re-entering data and cutting and pasting it across systems. Ketryx enables you to connect to ALL realtime systems across your department and enterprise.

Get products to market 2-3x faster without breaking things

Your first priority is always safety but with a unified process, your developers can move quickly with the confidence that they cannot make a move that is not consistent with approved SOPs. All changes are automatically tracked, evaluated, and approved. Higher risk processes, such as use of SOUP or Software of Unknown Provenance are automatically flagged.

Gain Peace of Mind with FDA-Ready Documentation

Preparing for audits requires a traceability matrix, among other documents, to ensure your systems are defensible. Ketryx overlays your existing QMS, workflows and dev tools to ensure traceability isn’t an afterthought and automatically compiles FDA-ready documentation from all systems. Built-in intelligence comes from in-house former FDA talent as well as other industry experts.

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Keep up with Regulatory Guidance

Cloud adoption is driving new guidance. FDA is increasingly shifting the burden of keeping up with cybersecurity to manufacturers. Ketryx streamlines this process, making it easy to keep up with patches and automates compilation of new documentation requests

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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Gain Process Control

Ensure SOPs are being followed exactly as written.

Move Fast; Maintain Product Integrity

End-to-End Lifecycle Management Using Your Favorite Development Tools