Penn Pharma – Transforming maintenance planning with IBM Maximo

Using IBM Maximo^® to plan maintenance and ensure regulatory compliance in a new, state-of-the-art pharma facility

Established over 35 years ago, Penn Pharma, a PCI company, delivers integrated drug development, clinical trial supply and manufacturing services for the healthcare industry.

Penn Pharma employs approximately 500 people in the UK, and its global parent company, PCI, employs around 3,200 people worldwide.

When PCI Pharma invested in its new state-of-the-art high-containment facility, it wanted to develop a much more proactive, predictive approach to maintenance planning.

PCI Pharma realized that an enterprise-class maintenance management system could also help meet the stringent regulations that apply to pharmaceutical manufacturing, and the growing expectations of its safety-conscious clients.

Building a Partnership with Peacock Engineering

PCI Pharma decided to deploy IBM Maximo^® Asset Management to transform maintenance planning at its new facility, and engaged Peacock Engineering to deliver the project.

Peacock Engineering were required to build, within hosted infrastructure at its Rackspace dedicated hosting centre, a new Maximo^® system and to import into it, data from a wide variety of sources. The system was tested and validated for GAMP jointly by Peacock Engineering staff and PCI Pharma QA staff.

As PCI Pharma transitioned to an online, paperfree system, it became necessary that they carried out electronic validation in accordance with FDA regulations, specifically 21 CFR Part 11. Their new system enabled them to carry out this audit trail effectively and thoroughly, and prove that they adhered to all regulations.

Increased efficiency & work order visibilityPCI Pharma now has a standalone Maximo^® system that is fully validated in accordance with FDA regulations, specifically 21 CFR Part 11.

By eliminating data duplication and reducing the scope for human error, the system contributes significantly to the overall safety of the plant.

Demonstrating robust regulatory compliance

PCI Pharma’s new solution plays a key role in demonstrating the new facility’s compliance with standards expected by regulators and clients. The IBM Maximo^® solution provides them with:

• A full digital audit trail for all maintenance work
• Transparent evidence that maintenance is reliably managed
• Proof that they meet all required standards

They can also now demonstrate that they prioritise Health and Safety in their contained manufacturing facility.

This is imperative to PCI Pharma’s employees and clients.

PCI Pharma realized that an enterprise-class maintenance management system could also help meet the stringent regulations that apply to pharmaceutical manufacturing, and the growing expectations of its safety-conscious clients.

Building a Partnership with Peacock Engineering

PCI Pharma decided to deploy IBM Maximo^® Asset Management to transform maintenance planning at its new facility, and engaged Peacock Engineering to deliver the project.

Peacock Engineering were required to build, within hosted infrastructure at its Rackspace dedicated hosting centre, a new Maximo^® system and to import into it, data from a wide variety of sources.

The system was tested and validated for GAMP jointly by Peacock Engineering staff and PCI Pharma QA staff.

Enabling a longer-term view to maintenanceThe IBM Maximo^® solution enables PCI Pharma to take a longer-term view towards maintenance management. They are now able to:

• Easily plan ahead, using insight from the IBM Maximo^® system
• Align maintenance with manufacturing schedules
• Migrate their existing manufacturing facility to the IBM Maximo^® solution
• Explore additional features – such as inventory management