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PHE Maximo Implementation and Enhanced Support and Maintenance

Electronic Data, Inc. managed the implementation of IBM Maximo for all Public Health England (PHE) plant maintenance and calibration activities for the entire campus in Porton, England.

Scope of Work Included:

EDI’s effort began with a Blueprinting process for the entire PHE project, which included the following:

Key elements of EDI’s Project Approach

Description of assessment findings and relationship to maintenance and compliance best practices and benchmarks
Recommendations on maintenance processes, policies, and procedures
To-Be process diagrams
Assessment of data sources and estimate to convert or develop key data elements
Initial Change Management Plan
Initial Communication Plan
Detailed Implementation Project Plan

Following the Blueprinting process, EDI began the Maximo V6 implementation, with the purpose of producing a validated Enterprise Asset Management (EAM) system to support cGxP Maintenance Operations. The system was then able to be used as the source for and management of all asset and maintenance related data and processes. This implementation resulted in the following:

Consistent, effective method of managing the installation and maintenance of cGxP assets
Unified information system, by combining information managed in two systems into one
Ability to easily report on cGxP asset inventory and maintenance history
Support of Calibration processes and data, which included the conversion of Blue Mountain Software calibration data to Maximo
Demonstration of control over maintenance operations suitable for regulatory audit
Provided Johnson Controls with effective billing and financial control over services being provided to PHE

A validated EAM system was the most cost-effective way to enhance PHE’s compliance and regulatory position. The specific compliance drivers for the implementation of this system included the following:

Demonstration of Compliance to 21 CFR Parts 11, 210, and 211
Single Source for Asset Records and Specifications
Electronic Job Plan Creation and Revision Control
Electronic Signature (E-sig) Enabled Dynamic Work Flows for Work Approval/Execution
cGxP Criticality Driven Workflows to Enable a Risk-Based Approach to Compliance in Maintenance Processes
Calibration Data Storage, Traceability and Corrective Actions
Spare Parts Assessment Based on GxP Criticality and/or Product Contact

EDI provided ongoing enhanced support for several years after the initial Maximo implementation in the form of annual support and maintenance. This consisted of two levels of support services. As part of Level 1 support, EDI deployed consistently available, dedicated support resources collectively possessing a broad, general degree of expertise for all supported programs. Level 1 support to End Users provided primary support for installation activities, including configuration problems, installation-related problems and post-installation reconfiguration. As part of Level 2 support, EDI deployed consistently available, dedicated support resources collectively possessing both broad and in-depth product expertise, including thorough knowledge of product interdependencies and relationships for all supported programs and the ability to recognize and determine the nature and extent of reported problems. Level 2 End User support consisted of performing problem troubleshooting and developing prevention plans and workarounds.