1. Customization of Core Modules:

During development, it’s critical to ensure that the system meets the specific needs of the
pharmaceutical industry. Modules like eBMR (Electronic Batch Manufacturing Records) and eBPCR (Electronic Batch Production Control
Records) are tailored to capture detailed production data, including time-stamped entries and digital signatures, while ensuring
compliance with regulatory bodies such as the FDA and EMA.

 

2. Regulatory Compliance in Development:

– One of the core aspects of development is ensuring that all modules are designed with regulatory compliance in mind.

– During development, the system must meet Good Automated Manufacturing Practices (GAMP 5) guidelines, ensuring the system’s software and hardware components are validated to perform their intended functions.

– To ensure the integrity and functionality of the system, both automated and manual testing are conducted at various stages of development.

 

3. Performance Optimization:

– The system needs to efficiently manage vast amounts of data, especially when handling real-time production inputs and IoT device
integrations. During development, performance optimization is crucial to ensure the system can process large datasets without lag or
performance bottlenecks.
– As part of the development process, scalability is built into the system to ensure that it can grow as the company expands, handling
more data, users, and integrated devices.

 

4. IoT Integration and Real-Time Data:

Development involves linking IoT devices used on production lines (such as sensors and smart equipment) with the system. The data
collected from these devices (e.g., temperature, pressure, equipment usage) is fed into modules like the eCalibration system for real -time tracking and analysis.

 

5. Post-Development and Continuous Improvement:

As the business grows, new functionalities can be added to the existing modules.