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Pfizer Newbridge, Legacy System Remediation

Client

Technology

Consultant

N/A

 

Project title: Legacy Systems Remediation
Description: Assess and remediate legacy systems to reflect current corporate requirements
Client: Pfizer Newbridge, Ireland
Technology: Rockwell, Siemens, Mitsubishi
Timeline: Nov 2008 – Nov 2011 (with interruptions)
Contact: Darrin McCrudden / darrin.mccrudden@cim.ie / +353 (0)1 885 3400

Background

  • The site was undertaking a legacy system remediation project but the process was found to be costly and paper intensive.
  • There were 138 automation systems remaining to be assessed / remediated.

Requirements

  • Remediate systems according to an suitable priority.
  • Review and seek to improve efficiency with current approach.
  • Build and manage team with necessary engineering and validation expertise.

Key Challenges & Solutions

  • Budget Restraints.
    The site remediation project was executed on a phased basis according to a priority assessment of the systems. In each phase we leveraged experience and brought increasing efficiencies to the process. We also balanced remediation effort with criticality and GMP footprint of the system.
  • Large number of diverse and old systems.
    We had previously completed an Automation Systems Audit project, which provided an insightful overview of all systems and clean fresh data on each system.

Implementation

  • We risk assessed each system and prioritised remediation in a manner that reflected business criticality of system, perceived validation and part 11 compliance, preliminary system assessment and the projected life span of system.
  • We redesigned the site’s generic Legacy Assessment Form to a matrix format that facilitated cleaner and leaner data presentation and focused it more on the perspective of automation systems. The more concise approach typically reduced the assessment form from approximately 27 to 2 pages and led to quicker compilation, review and approval of the document.
  • We reduced the range of issues checked in the assessment by leveraging the site’s periodic review process which overlapped with some areas of the assessment.
  • In essence there were 2 steps to the remediation process, first assess the system to identify any gaps and then address the gaps by validation, technical, procedural actions.
  • On subsequent phases of the project, we were able to leverage remediation precedence to eliminate the requirement for a system specific remediation plan and captured the final status in the Legacy Assessment Form.

Benefits

  • The project ensured legacy system compliance with current corporate requirements.
  • The remediation process and documentation are leveraged strongly during reviews and audits.

n A photographic library of in-situ automation systems and hardware which reduces the need to enter the production environment, saving time and cost (gowning process).