CASE STUDY
Preliminary Engineering Engagement Lays Groundwork for Digital Transformation in Biologics Manufacturing
Global biopharmaceutical contract development and manufacturing organization (CDMO)
Biopharmaceutical Manufacturing
Onsite Controls Engineering Support; User Requirements Specification Development; Network Infrastructure Evaluation; Data Source Mapping; RFQ Preparation for System Integration
Overview
TM Process & Controls, Inc. (TMPC) ICS Cybersecurity engineers were engaged to perform an in-depth preliminary engineering assessment at a biologics manufacturing site in Washington State. Over the course of eight weeks, onsite ICS Cybersecurity engineers worked to identify production, laboratory, environmental, and maintenance data sources while also reviewing the customer’s IT infrastructure. This work established the technical and operational foundation for future electronic batch record (EBR) implementation.
Problem
The customer sought to move away from paper-based batch records but lacked a comprehensive understanding of their current systems, data flow, and network infrastructure across multiple functional areas, including production, QC/QA, EHS, and maintenance.
Solution
TMPC deployed onsite engineers to evaluate existing documentation, meet with stakeholders, identify critical data sources, and define network architecture. A robust RFQ package was then developed, enabling the customer to seek implementation quotes from qualified system integrators for a compliant, integrated digital batch record solution.
Results
- Comprehensive user requirement documentation and infrastructure mapping
- Identification of key integration points and hardware/software needs
- RFQ package delivered to facilitate a competitive bidding process
- Established a strategic roadmap toward full EBR system deployment
