Advancing Biotech with IT Excellence

Saros Consulting partnered with a leading global biotechnology company to oversee a significant IT infrastructure project as part of a larger Vial Fill modernisation initiative at their Dun Laoghaire facility in Dublin. This project, spanning from March 2021 to November 2023, was a critical venture in a sector where precision and innovative solutions are essential.

 

Client Overview

The client, a prominent name in the biotechnology sector, aimed to expand and modernise its Vial Fill line. This required the implementation of an advanced IT system that adhered to the rigorous Good Manufacture Practices (GMP) of the pharmaceutical industry. This project was more than a technical upgrade; it was a strategic component of the client’s growth plan.

 

Objective: A Technological Leap Forward

Our objective involved managing the installation, setup, and integration of a state-of-the-art IT system. This comprehensive undertaking included overseeing the entire IT Basis of design, covering network hardware, server hardware, cellular distribution antenna system (DAS) extension, high availability architecture, software requirements, and robust cybersecurity measures aligned with the strict Good Manufacture Practices (GMP) of the pharmaceutical industry.

 

Scope of Work

Saros Consulting’s role spanned the entire project management lifecycle, from orchestrating the IS infrastructure to coordinating with remote vendors during critical commissioning and startup phases, ensuring every aspect was geared towards operational excellence.

• Orchestrating the source, build, and delivery of IS infrastructure as per design.
• SQL Database design for all systems
• Validating software and server hardware for operational readiness
• Facilitating network design within ECR, ensuring robustness,
• Overseeing the timely procurement of all IT equipment required to meet deadlines.
• Supervising servers build requests, firewall changes, and account setups.
• Coordinating remote vendor support during crucial commissioning and start-up phases.

 

Approach: Tailored and Strategic

In alignment with the client’s approach for managing deliverables and adhering to the methodologies and governance models supplied, Saros adopted a flexible, resource-optimised strategy. This involved drafting critical project documents, establishing effective communication channels, and implementing risk management protocols, demonstrating our structured yet adaptable approach to project management.

 

Challenges and Solutions: Navigating Complexities

Our project management expertise was crucial in overcoming challenges such as coordinating across various departments and contractors, and integrating AV equipment in clean rooms. Acting as a central hub, we ensured smooth collaboration and compliance with stringent standards.

 

Coordinating Across Departments and Contractors:

Saros Consulting provided expert project management, serving as the central coordinator for various internal and external teams, including the client’s Automation and Information service departments, along with several external contractors. This enabled what was a complex logistical challenge, essential for project continuity to be coordinated centrally with Saros acting as a management and communication hub, ensuring all parties were aligned with project goals, facilitating effective collaboration and timely completion of project milestones.

 

Integrating AV Equipment in Clean Rooms:

The integration of AV equipment into regulated clean rooms was a technical challenge which required compliance with strict cleanliness standards. Saros coordinated with AV specialists to install custom enclosures for AV equipment, ensuring compliance with clean room standards without compromising functionality.

 

Remote Vendor Access Setup:

A key component of the IT project was establishing secure remote access for vendors to the complex production equipment. This process entailed obtaining approvals through the client’s internal procedures for various essential secured hardware components connected to the production system. Additionally, it involved integrating the vendor’s selected remote access software, which allows for remote connectivity through the client’s firewalls. This setup was vital for facilitating remote setup, configuration, and support of the production system.

 

Outcomes: Successful Technological Transformation

The project culminated in the successful implementation of a robust IT infrastructure. Key achievements included the timely setup of all necessary IT components, effective cybersecurity measures, and a smooth transition to ongoing business operations. These successes highlight our capability in managing complex, multifaceted projects in highly regulated environments.

This project demonstrates Saros Consulting’s expertise in managing complex IT projects within the pharmaceutical industry. This case study showcases our technical expertise and our ability to navigate complex regulatory environments, manage projects with diverse stakeholder groups, and overcome technical challenges.