Wyeth Pharmaceuticals, Pearl River, NY

The 550-acre complex, located in Rockland County approximately 20 miles north of New York City, employs approximately 3,200 people and is one of the largest manufacturing and research facilities in Wyeth’s global network.

Wyeth Pharmaceuticals, Pearl River, NY

Wyeth LogoWyeth Pearl River purchased CalMan 4.2 as their corporate computerized calibration management system (CCMS) solution. They had begun the task of converting from their paper based calibration system to their new CCMS when ITS became involved.  At the same time, Pearl River was also the trial site implementing a new, custom developed data transfer system (Integration/Conversion Program) between their new CCMS and their existing corporate computerized maintenance management system (CMMS) solution Maximo.  In a sense, the Pearl River site had become the proving site for the new CCMS and the new custom data transfer system.

Pearl River had about 30,000 items in their current calibration program and about 50 calibration technicians performing the monthly Cal schedule with many more supporting their efforts. For example, admins who generated the monthly paper based packages of Cal work sheets and processed the returning executed Cals, technical staff who managed the inevitable OOT’s & OOF’s, technical and quality who reviewed finished Cal Work Sheets and of course management trying to keep the mountain of work under control.

The need for all this change was the result of a FDA Audit that resulted in several consent decrees against Wyeth and one of those concerned calibration issues.

OBJECTIVES:

  • To rationalize the 30,000 or so individual paper based calibration specifications into a minimum set of internally approved ‘one-for-many’ CalMan MDT’s
  • Loop Calibrations were desirable
  • To deploy their new CCMS across all areas of the site
  • To integrate the new CalMan CCMS with the existing Maximo CMMS utilizing the custom Transfer Program
  • The CCMS, CMMS and the custom Transfer Program had been previously Validated

THE PROBLEM – CalMan Pearl River did not have the manpower to achieve the Objectives while maintaining the on-going Calibration Schedule and finish in time to meet the Consent Decree timeline.

THE SOLUTION – Hire a Contractor / Consultant who was qualified to generate the MDT’s (both CCMS and Calibration expertise). ITS was selected because of our ProCal and Calibration resources and successful Project Management credentials.

ITS provided the following Project Services:

  • Delivered a coordinated set of MDT’s ready for Customer Approval
  • Where possible created Loop MDT’s to support Loop Calibrations
  • Managed the Wyeth MDT Approval process
  • Developed the complete Deployment Plan
  • Managed the development & execution of System Training
  • Developed & Managed the Implementation Trial
  • Collected & Analyzed Implementation Trial Feedback & Metrics
  • Tested the CCMS to CMMS Interface and provided Pearl River Management with a comprehensive Interface ‘Fit for Use’ Report
  • Development of new System and MDT Lifecycle SOP’s and Consulted in the revision process of existing Calibration SOP’s to allow them to seamlessly integrated into the new CCMS

THE RESULTS

  • MDT’s created and approved
  • Successful Implementation Trial
  • Interface ‘Fit for Use’ Report concluded that the CCMS / CMMS Interface was not sufficiently reliable for use in a validated environment
  • Wyeth Management decided to abandon the CCMS / CMMS Interface in place and proceeded with the implementation of a manual data transfer option
  • 50 CalMan equipped Laptops were deployed to Calibration Technicians across the Pearl River Site – making it, perhaps the largest CalMan Implementation ever deployed