Engineering Compliance.
Accelerating Innovation.
We develop intelligent software solutions for regulated environments. Bridging the gap between cutting-edge Data Science and rigorous GxP compliance.
Our Products
Software built to solve real regulatory challenges.
SourLemons
An AI-assisted review layer for GMP audit trails. Designed for QA and CSV teams dealing with large, complex datasets. Built with Annex 11 / Annex 22 thinking in mind.
- ✓ Risk-based prioritisation
- ✓ Human-in-the-loop by design
- ✓ Machine Learning anomaly detection
Why product-led compliance?
Generic IT tools fail in regulated life science environments. We build domain-specific products that integrate natively into your validation lifecycle and Quality Management System.
Pipeline
While SourLemons is our flagship solution for Audit Trail Reviews, we are actively researching and developing further LLM-based applications to automate CSV documentation and validation testing.
By CSV Engineers,
For CSV Engineers.
The pharmaceutical industry suffers from outdated manual review processes. We founded nojirec GmbH because we experienced the pain of inefficient Audit Trail Reviews firsthand in our daily work.
Combining a deep academic background in Biotechnology and Data Science with years of practical experience in Computer System Validation, Michael and Philipp established nojirec to bring modern Software Engineering standards to GMP compliance.
GxP Expertise
Deep understanding of FDA 21 CFR Part 11 and EU GMP Annex 11 requirements.
Applied AI
Leveraging Machine Learning and LLMs to solve specific validation bottlenecks.