Pharmaceutical industry · Rubí, Barcelona
From reactor data to the manufacturing report.
From manually preparing the production report to generating it automatically with an application, using data captured from the process. The deployment covers all reactors at the plant.
The challenge
Bring process data together with batch context and make it available for review. The challenge went beyond data capture: the solution had to fit the pharmaceutical environment's security and traceability requirements.
The implemented solution
An application reads PLC values and retains them in historical records. The production report, previously prepared manually, is generated automatically from this data, with charts and tables linked to the equipment, product and batch. The deployment covers all reactors at the plant.
Capture
From the PLC to a history of process variables
Data capture combines numerical values and equipment states, according to the variables configured for each reactor. The application communicates with the PLC over Ethernet, recording time-stamped readings. This preserves the evolution of the process rather than just an isolated value.
- Reading measurements such as temperature and digital states such as the agitator being on or off.
- Configuration of variables and process limits.
Analyse
From readings to an automatic production report
Historical data is reviewed in the context of the equipment, product, batch and manufacturing period. The report previously prepared by hand is generated automatically from recorded data, bringing together trend charts, equipment states and value tables in one document to support process review.
- Charts to interpret measurement trends and the sequence of equipment states during manufacturing.
- PDF reports with batch context and manufacturing data, without manually transcribing readings.
Regulatory compliance
Security and traceability built into the process
The solution was developed to meet the applicable requirements of 21 CFR Part 11 and fit the company's procedures. The challenge is not just collecting data: it also involves controlling access, retaining traceability of changes and protecting information throughout its lifecycle. The application therefore integrates with corporate security mechanisms rather than creating a separate user and password system.
- Active Directory-based authentication and permissions, with an Audit Trail recording changes and actions.
- Data retained within the organisation, protected by its network controls and backup and recovery procedures.
Process data with the traceability and control required in a pharmaceutical environment.
A solution developed to meet the applicable requirements of 21 CFR Part 11, integrated with the company's security procedures: Active Directory-based user permissions, an Audit Trail of changes and actions, and backup and recovery mechanisms to protect and retain manufacturing information.
Integrated security
Aligned with the company's security and data protection procedures.
Active Directory
Corporate users and permissions, without storing passwords in the application.
Audit Trail
A record of changes and actions to support information traceability.
Retention and recovery
Backup and recovery mechanisms within the organisation.