Modernising Mission-Critical IT Infrastructure for a Global Biotechnology Company 

Client Challenge: A Critical IT Infrastructure Overhaul 

A global biotechnology company faced the challenge of modernising its Vial Fill line while maintaining critical operational continuity. This formed part of a larger strategic initiative to expand operations at its facility in Dublin, Ireland and support the company’s growth plans. The project involved the implementation of an advanced state-of-the-art IT system, adhering to the strict Good Manufacturing Practices (GMP) of the pharmaceutical industry. This required a comprehensive overhaul of the IT infrastructure, including network hardware, server architecture, and cybersecurity, with zero tolerance for operational disruption or non-compliance. 

Client Need: Partner with Expertise in Regulated, Complex IT Projects 

Saros Consulting was selected for this mission-critical initiative due to our deep expertise in managing complex IT infrastructure projects within regulated industries such as biotechnology and pharmaceuticals. Our proficiency in adhering to stringent GMP standards, combined with our ability to coordinate large-scale system integration projects, positioned us as the ideal partner for this endeavour. Our track record of overseeing the procurement and delivery of innovative solutions while maintaining strict compliance and business continuity further reinforced the client’s trust in our capabilities. 

Saros Consulting Approach: Tailored Strategy and Central Coordination 

Adopting a flexible, resource-optimised strategy, Saros aligned its project management approach with the client’s programme approach, adhering to the preferred methodologies and governance models. Acting as the central coordination hub, we ensured smooth collaboration between internal departments and external contractors throughout the project. This included drafting project charters, quality plans and stakeholder management plans.  

By establishing clear communication channels and implementing risk management protocols, we ensured that all stakeholders remained aligned, effectively navigating the complexities of this large-scale IT integration project. 

Seamless Integration with a Focus on Excellence  

Our role involved project managing the entire IS infrastructure to meet the client’s complex design and operational requirements. This included overseeing the configuration, integration and support of critical systems during the critical commissioning and startup phases. 

• Robust IT Infrastructure: Orchestrated the source, build, and delivery a fully integrated IS infrastructure, including SQL database design for all systems. Coordinated design and delivery of network hardware, cellular DAS extension, server hardware, and advanced cybersecurity aligned with GMP standards. Supervised server build requests, firewall changes, and account setups. 

• AV Integration in Clean Rooms: Coordinated the successful installation of AV equipment in regulated clean rooms, ensuring compliance with stringent cleanliness standards. 

• Remote Vendor Access Setup: Established secure remote access through the client’s firewalls, allowing vendors to configure and support critical production equipment without delays. 

• Timely Equipment Procurement: Facilitated on-time procurement and setup of all IT components, ensuring deadlines were met despite complex coordination challenges. 

 

The Outcome: Successful Technological Transformation, Robust Data Governance & Improved Cyber Security. 

The project concluded with the successful implementation of a cutting-edge IT infrastructure that met the client’s operational and regulatory requirements. Saros Consulting’s efforts enhanced the efficiency of the client’s Vial Fill line, enabling them to support their operational expansion with a modern, resilient system. The IT infrastructure adhered to stringent Good Manufacturing Practices (GMP), ensuring robust data governance and cybersecurity measures.  

Throughout the project, business continuity was maintained without any disruption to ongoing operations, safeguarding full productivity. The cybersecurity architecture implemented by Saros protected sensitive data while allowing secure remote access for vendors, enabling efficient support and management of the system. These achievements underscore Saros Consulting’s expertise in delivering complex IT infrastructure solutions in highly regulated environments. 

 

Saros Capabilities: Leading Complex IT Transformations 

• IT Infrastructure Expertise: In-depth experience in overseeing the design and delivery of IT systems in highly regulated environments.

• Compliance and Risk Management: Strong governance frameworks ensuring adherence to GMP standards, risk mitigation, and regulatory compliance. 

• Cross-Department Coordination: Proven ability to manage complex projects involving multiple stakeholders and including internal departments, external contractors, and vendors. 

• Cybersecurity & Remote Access: Expertise in establishing secure, compliant remote access for critical system management. 

 

This project exemplifies Saros Consulting’s strength in delivering comprehensive IT infrastructure solutions in highly regulated environments, blending technical expertise, seamless coordination, and an unwavering commitment to operational excellence.