Greater Efficiency for Pharma Customer

This project was done for Biofarmitalia, a pharmaceutical company that’s been in business for more than 20 years. Biofarmitalia develops new technologies for cosmetic and pharmaceutical applications. The project was aimed at managing IT infrastructure used for quality control analysis integrating 18 types of equipment (PHmeters, scales, HPLC, GC, Spectrophotometer, TOC Analyzer, conductivity, moisture analyzer, refractometer, polarimeter, water analyzer). All analysis data is collected according to data integrity, CFR21, and GAMP5 compliance.

Y-Lab System, based on Ignition, controls GMP master data, dynamic data on real-time acquisition, audit trail report and analysis/batch reports, analysis approval workflow, and alert notifications on triggered events.

Problem:

Y-lab is meant to solve operative issues related to data integrity, avoid analytic data prefetching, and to provide data governance tools during laboratory activities.

Solution:

Y-Lab system has been developed on Ignition version 7.9.8. The system landscape has been designed in order to define a scale-up logic: development environment is used as a sandbox, test environment is used for test, acceptance and validation system, production environment is used for running business purpose.

Equipment is connected to Ignition via RS-232 interfaces, managed with the Serial module.

Analytic devices are provided by panel PC connected to Ignition server. All data detected by each piece of equipment is processed and transmitted to the connected PostgreSQL DB instance.

Several scripts have been implemented in order to manage data acquisition, result recording, printout, and master data.

Software versions are managed by a tag with history data logger. Project changes are imported between system environments using Atlassian BitBucket.

User access to the system is regulated by the customer’s AD Profile integration with SSO, according to authorization.

Alarm Notification module provides email notification on alarm events. Sepasoft Instrument Interface module has been used to parse incoming data from the RS-232 equipment.

Analysis processes can be summarized in 3 macro-categories:

• RTPD - Real Time Process Data
• SSPD - Start and Stop Process Data
• SSFT - Server-Side File Transfer

For each process/flow, it is possible to consult/print the reports. In RTPD mode the system records in real time all data exchanged with the equipment; in SSFT mode the system intercepts the HPLC/GC analysis files and stores data; in SSPD mode the system records in real time start/stop point of an analysis process.

The solution offers highly valued technology, integrating poor instrumentation into a solid regulated system with GMP data integrity, and is data-governance oriented. Moreover, the inexpensive cost makes it easily approachable and efficient.

Results:

• Paperless approach
• Processes optimization in the whole data lifecycle
• GMP data integrity security compliance
• Easy data governance, reporting, and auditing

Before this project, business processes were documented only on paper, involving high user effort, implying data unreliability and continuous checking and re-cycles. Y-Lab has been designed to be easy to validate, versatile, and easy to enhance.