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The challenge: limited in-house resource for software system management

This world leading research based pharmaceutical company operates out of two main sites in Ireland for worldwide distribution of medicines and vaccines. The company is responsible for the manufacturing of bulk active pharmaceutical ingredients (APIs) and producing biomedicines for both the treatment of immune related diseases and new, innovative cancer treatments.

These manufacturing facilities required external support from Zenith to ensure their IT systems operate continuously, optimally and to prevent manufacturing downtime.

The company also continuously strives to improve its operations and regularly invests in upgrading its core manufacturing IT systems. They required expert support during both the software and hardware installation process, then in integrating these systems with existing systems, as well as validation support.

Resource limitations within the organization meant that a very small team, whose primary focus is on global or strategic business directives, didn’t have the capacity or focus to manage day-to-day manufacturing systems on-site. As a result, the company required an external partner to run its managed services, ensuring the IT systems operate efficiently and continuously to prevent manufacturing downtime.

The solution: an exceptional relationship

The partnership began in 2012 when the customer began a three-year managed services contract. Initially Zenith provided eight highly skilled team members on-site to manage day-to-day MES and automation processes, deliver and support on a range of small projects, such as new equipment installations, and validate new systems and processes.  Since then Zenith’s role has broadened significantly to include support for lab services and IT with over 60 people now working on-site or by remote dial-in across both facilities. ZT is also responsible for providing 24 hour on call service to production to ensure no downtime or loss of batch. This three-year deal was renewed in 2015 and again, earlier this year (2018).

The Zenith service management processes focus on ensuring that the MES and Automation systems are managed, supported and maintained in a consistent, repeatable, compliant and cost-effective manner. To achieve this, Zenith:

• Introduced a new incident management tool which enabled the analysis of trends in support issues.
• Acts as the single point of contact for the reporting of all site incidents and provides incident response to the client 24 hours per day, 7 days a week and 52 weeks a year to prevent downtime or loss of batch.
• Provides a full range of management and execution processes to satisfy both the day-to-day operational support and project support. Both of which are required to effectively operate a large scale GMP manufacturing and laboratory facility using predefined standard processes and ways of working.
• Maintains the validated state of the client’s automation systems and performs periodic reviews of the automation and MES systems as per each platform’s Standard Operating Procedures (SOPs), which dictate software reviews and account re-certifications.
• Trains operators on site and undertaking quarterly production walk downs to give operators an opportunity to discuss any queries or concerns they have when using the control systems. Zenith also develops Knowledge Based Articles when resolving problems to allow operators to manage these issues themselves should they recur.

Benefits of ZT’s Managed Services to the customer

• A standardised approach to automation and validation
• Project support for new software and hardware installation
• Significant resource availability – 60+ members of ZT personnel
• Compliance peace of mind and system security
• Improved production processes, operations actively working on Continuous Improvement
• Incident assurance, minimal downtime and risk of damaged batch or batch loss

Outcome: improved production processes, reduced risk and cost savings

Over £500,000 in savings was achieved over a 12-month period (2017-18) as a direct result of Zenith’s ownership of small hardware and software upgrade projects and managing the integration and validation.

Zenith has successfully implemented and qualified major system upgrades including Pas-X and Honeywell and provided additional hypercare to ensure production was unaffected by each upgrade.

The partnership has led to improved production processes, operations actively working on continuous improvement, greater incident assurance, minimal downtime associated with automated systems and reduced risk of damaged batch or batch loss.

At a glance:

Brief	Challenges	Solution	Results
Company: Top 10 global pharmaceutical manufacturer Location: Ireland Mission:  Provide comprehensive day-to-day management of MES and automation processes, deliver and support on a range of small projects. Product/services: Managed services	Limited Resources Continuous improvement through hardware and software upgrades	24/7 365 incident. A standarised approach to automation and validation Project support for new software and hardware installation. Significant resource availability – 60+ members of Zenith personal	Improved production processes, operations actively working on continuous improvement Incident assurance, minimal downtime and risk of damaged batch or batch loss. Over £500,000 in savings have been achieved over a 12-month period

 

 

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