How Foresight Diagnostics Reduced Documentation Time by 80%
Foresight Diagnostics is a biotechnology company developing advanced diagnostic tools for detecting minimal residual disease (MRD) in cancer patients. The company leverages cutting-edge genomic and molecular techniques to provide highly sensitive diagnostic tests, which can help in monitoring recurrence. These diagnostics will have the opportunity to improve personalized cancer treatment by enabling clinicians to make informed decisions about patient care based on precise and early detection of residual disease. Foresight accelerated their release cycles with Ketryx by decreasing documentation time by 80% and onboarding developers more quickly, all of which helps them get their life-saving product to market faster.
Impact
80%
Reduction in documentation time
62304
Full support for IEC 62304 compliance
Industry
BioTech
Device Type
Cancer Diagnostic
Tech Stack
Jira, GitHub
Customer pain points
Manual documentation delayed release cycles
Before Ketryx, the Foresight team spent days per release on highly manual documentation, which delayed their release cycles.
- Developers new to the regulated software domain struggled with the complexity of generating and tracing FDA-required documentation.
- The team wanted to move fast, and realized that they didn't have the time or capacity to build and maintain a custom solution.
The Ketryx solution
IEC 62304 compliance, automatically
Foresight Diagnostics sought a solution to streamline SDLC management and selected Ketryx to achieve the following objectives:
- 62304 Compliance: Ketryx provides full support for IEC 62304 compliance, addressing key needs like traceability, risk management, FDA compliance, and medical device documentation.
- End-to-End Traceability: Ketryx effectively establishes traceability across the development lifecycle.
- Fast Onboarding: Ketryx is quick to implement and integrates well with existing tools like Jira and GitHub, providing a seamless and efficient solution without the need for extensive setup or additional resources.
Business outcomes
Documenting, developing, and onboarding faster
With Ketryx, the Foresight team quickly realized several key benefits:
- Reduced Documentation Time by 80%: Foresight was able to generate accurate, comprehensive documentation that met QA and regulatory standards 5x faster than before – from one week to one day per release cycle.
- Resource Efficiency: By automating the traceability and documentation processes, Ketryx reduced the need for manual input from developers and the need for additional technical writers, thereby saving time and resources.
- Faster Developer Onboarding: The integration with existing tools and the clear release checklist provided by Ketryx improved workflow efficiency, allowing the team to manage and track development activities more effectively and with greater clarity. The checklist allowed Foresight to quickly onboard new developers into the regulated software domain.
"I used a traditional ALM in the past and it didn’t have the traceability I needed, especially tracing from my test executions and results. It also created duplicate work since I needed to go update my work there every time I completed a task. Ketryx updates itself as I’m working in Jira and GitHub. This tighter integration into our current tools helps us be more productive and release faster."
Aaron Berlin
SVP Development and Engineering
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