Published on: June 15, 2025
Author: Michele Lacorte, CTO
A leading pharmaceutical company needed to strengthen batch traceability, ensure regulatory compliance, and improve integration between production lines and ERP/GMP systems.
In highly regulated environments like the pharmaceutical sector, collecting accurate and traceable data is essential. However, the company had to manage manual processes, isolated systems, and difficult data validation for inspection and audit purposes.
- Lack of continuous traceability along the line
- Poor integration between field and ERP systems
- Risk of non-compliance in FDA and GMP audits
By implementing Meddle, the company would gain access to a centralized and configurable supervision system capable of automatically collecting process data from machines and sensors, ensuring compliance with pharmaceutical and biotech regulations.
- End-to-end traceability of production batches
- Data validation compliant with FDA/GMP regulations
- Seamless integration with ERP and quality systems
- Secure and auditable storage of collected data
Meddle delivers immediate and measurable benefits:
- Easier preparation for audits and inspections
- Automated process documentation
- Reduced risk of non-compliance
- Better integration between field and central systems
Meddle is designed to support regulated companies in digitalizing their processes, ensuring data integrity, security, and compliance with major international standards such as FDA 21 CFR Part 11, GAMP5, and GMP.