Enforcement
Prevent process deviation across preferred DevTools
Ketryx embeds engineering controls that let developers move faster, have fewer meetings, and code more – while still ensuring compliance. Infuse quality into every stage of the product life cycle, ensuring quality at the source and compliance throughout the process.
I’ve been looking for this tool all my life!
Senior Director of Agile Transformation
The root cause of slower time to market
Large medical device companies have hundreds of developers working concurrently, remotely and around the world, on many different features, and in many different versions, for one release. With this level of complexity, it’s impossible – and risky – to rely on manual enforcement of your QMS procedures.
We can only release every 24 months.
Get full control with Ketryx
Reduce risk with Engineering Controls
The Benefits of Compliance by Design
Gain control and complete transparency for software releases and ensure FDA compliance prior to launch of any new product or version.
Rapidly onboard and keep developers happy by eliminating time spent referencing or verifying procedures.
Guardrails automatically stop any product from progressing until it is compliant, turning any developer into a regulated developer.
Prevent process deviation by enforcing your standard operating procedures in development tools like Jira and GitHub.
The right actions in the right order
Ensure that traceability is established before release with built-in controls in Jira.
Part 11-compliant signatures and configurable approval rules create streamlined workflows.
Maintain FDA-compliant data integrity
Live traceability tracks changes to avoid errors common in copy-pasting data across different systems.
SOPs are built into Ketryx to provide checks and prevent errors as developers work across risk-based projects.
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Prevent process deviation
Built-in coaching in Jira and GitHub highlights the highest risk items and their dependencies.
… without sacrificing speed
Higher quality doesn’t need to mean slower development.
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See how Beacon Biosignals achieved two-week development cycles.
Read the case study.png)