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The pharmaceutical industry suffers from outdated manual review processes.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 nojitec 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 nojitec 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.
Legal Notice
Information in accordance with ECG, UGB and Media Act (Austria) and relevant EU regulations.
Media Owner & Operator
Nojitec GmbH
7210 Mattersburg
Austria
Managing Directors: Philipp Wanka, Michael Werfring
Company register number: FN 684836 m
Company register court:
Regional Court Eisenstadt
VAT ID: ATU83606705
Contact: [email protected]
Purpose of the Website
This website serves to provide information about Nojitec GmbH and to present its software products and services in the field of digital compliance, audit trail analysis, and quality assurance in regulated environments (e.g., GMP).
The content is aimed at professionals in the pharma, biotech, and MedTech industries and serves exclusively for general information, product presentation, and technical classification.
It constitutes neither a binding service offer nor legal or regulatory advice.
Disclosure pursuant to § 25 Media Act
Media owner: Nojitec GmbH, registered office 7210 Mattersburg, Austria
Business purpose: Development, production, customisation and distribution of software solutions, trade in software licences, distribution of own products and services in Austria and abroad, and participation in companies.
Editorial line: Information about Nojitec GmbH and its software products and services (see “Purpose of the Website”).
Liability for Content
The contents of this website have been created with the greatest possible care. However, no guarantee can be given for the correctness, completeness, and topicality of the contents.
Liability for Links
This website may contain links to external third-party websites over whose content we have no influence. Therefore, no liability is assumed for this external content.
Copyright
The contents of this website are subject to Austrian copyright law. Any duplication, processing, or distribution outside the limits of copyright law requires the prior written consent of the website operator.
Privacy
Information on data protection can be found in the Privacy Policy on this website.
Privacy Policy
Information pursuant to Art. 13 and 14 GDPR
1. Controller
Responsible for the processing of personal data on this website is:
Nojitec GmbH
7210 Mattersburg
Austria
E-Mail: [email protected]
2. General Information
The protection of your personal data is a special concern of ours. We process your data exclusively on the basis of the statutory provisions (GDPR, TKG 2021).
This privacy policy informs you about the nature, scope, and purpose of the processing of personal data on this website.
3. Hosting & Content Delivery Network (CDN)
This website is hosted on a server operated by ourselves; no external hosting provider is involved.
This website is delivered via Cloudflare, Inc. (101 Townsend St., San Francisco, CA 94107, USA). Cloudflare acts as a Content Delivery Network (CDN) and security service provider.
Technical access data (e.g., IP address, browser type, operating system, referrer URL) is processed to provide the website securely and with high performance.
Data processing is carried out on the basis of Art. 6 (1) (f) GDPR (legitimate interest in security, stability, and performance).
Cloudflare is certified under the EU-U.S. Data Privacy Framework.
4. Server Log Files
When visiting this website, information is automatically recorded in so-called server log files. This includes, among others:
- IP Address
- Date and time of access
- Browser type and version
- Operating System
- Referrer-URL
- Requested page and HTTP status code
These data serve exclusively for technical operation, error analysis and defence against attacks. They are not merged with other data sources or used to create user profiles.
Legal basis is Art. 6 (1) (f) GDPR (legitimate interest in the secure and stable operation of the website). Log files are automatically deleted after 14 days at the latest, unless longer retention is required to investigate a specific security incident.
5. Cookies
This website uses only technically necessary cookies required for the operation and security of the website.
No tracking or marketing cookies are used without your express consent.
6. Your Rights
You are generally entitled to the following rights:
- Right of access (Art. 15 GDPR)
- Right to rectification (Art. 16 GDPR)
- Right to erasure (Art. 17 GDPR)
- Right to restriction of processing (Art. 18 GDPR)
- Right to data portability (Art. 20 GDPR)
- Right to object (Art. 21 GDPR)
- Right to withdraw consent (Art. 7 (3) GDPR)
7. Right of Appeal
If you believe that the processing of your personal data violates the GDPR, you have the right to complain to the responsible supervisory authority.
In Austria, this is the Data Protection Authority:
Austrian Data Protection Authority, Barichgasse 40–42, 1030 Vienna
https://www.dsb.gv.at