Integrator

The client was facing significant challenges managing eight bioreactor skids from OEM. The upstream line operated as islands of automation (each system having its own HMI, Alarm and Events Database). The skids themselves were restricted in functionality from the vendor leaving the client unable to tailor operations to their process needs.

They were seeking:
A centralized orchestration platform to control all eight bioreactors.
A full ISA-88-compliant batch system to enable recipe development and execution without constraints for all 8 bioreactors from one platform
A unified environment for batch logs and reporting, alarms, audit trails, and equipment control.

Solution:
The system features standardized tag templates aligned with instrument types, ensuring consistency and ease of configuration across all integrated equipment.
Standardized recipe management for site’s OEM provided bioreactor skids, providing operators with centralized access and streamlined workflows.
Central alarm management and Comprehensive batch reports supporting traceability and review.
Fully compliant with 21 CFR Part 11, meeting regulatory requirements for electronic records and signatures.

Business Outcome:
Improved Operational Efficiency and Regulatory Compliance: The solution significantly reduces manual effort, improves system reliability, and accelerates batch release timelines. With full 21 CFR Part 11 compliance, it also ensures audit readiness and minimizes compliance risk—ultimately leading to faster time-to-market and improved data integrity across all OEM skids.