Pharmaceutical Case Study

Background:

New Contract Pharma company acquired its first manufacturing plant from a large global pharma. Over 15 systems and data to be migrated within one year including SAP and network infrastructure. Failure to complete on time would result in significant financial penalties and potential cessation of the business.

Project Context:

The original SAP strategy was based on a clone/carve out of the production enterprise system. Weeks were spent negotiating with the internal organizations only to learn that the seller would not support a clone approach. During that time, three months had elapsed on the Transition Services Agreement and no formal planning had been completed for any of the IT work streams.

Engagement Approach and Solution

TMG was engaged by the Chief Operating Officer to craft a feasible IT strategy that could recover lost time. Our analysis revealed that the original SAP carve out approach would have resulted in less than 10% of the needed functionality and would take the same amount of time as a new greenfield implementation.
After evaluating several implementation vendors, TMG selected new partners that could provide a generic pharmaceutical template based on core ECC that would require minimal configuration.

Outcomes

  • New SAP System implemented and validated in 7 months (two weeks ahead of TSA deadline)
  • Reduced licensing cost by $2.5M
  • Development savings of $4M
  • Manufacturing operations uninterrupted
  • $1M in penalties avoided
  • Fully Autonomous IT infrastructure

Services offered

SAP Strategy, Program Management, Laboratory Systems, Computer Systems Validation
“In addition to their technical knowledge, TMG’s deep understanding of FDA regulations ensured that we maintained GMP compliance during execution and provided guidance to our Quality Assurance group. “
Jim Scandura
Chief Operating Officer
Avara Pharmaceutical Services