Pharmaceutical Case Study

A newly established Contract Pharma company has acquired its first manufacturing plant from a major global pharmaceutical entity. The ambitious project involves migrating over 15 critical systems and data within a tight one-year timeline, including SAP and network infrastructure. Timely completion is imperative to avoid substantial financial penalties and potential business disruptions.

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Project Context

The initial SAP strategy centered on cloning or carving out the production enterprise system from the seller's infrastructure. Despite extensive negotiations with internal stakeholders, it became evident that the seller would not support the clone approach. This realization occurred after three months under the Transition Services Agreement, during which no formal planning had been initiated for any of the IT workstreams.

Engagement Approach and Solution

The Chief Operating Officer enlisted us to develop a viable IT strategy aimed at recovering lost time. Our analysis determined that the initial SAP carve-out plan would have delivered less than 10% of the required functionality and would have taken as long as starting anew with a greenfield implementation. Following a thorough evaluation of various implementation vendors, we chose new partners capable of offering a generic pharmaceutical template based on core ECC. This solution minimizes configuration needs while ensuring efficient implementation.

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Achievements

  • Successfully Implemented and Validated the New Sap System in 7 Months, Completing Two Weeks Ahead of the TSA Deadline.
  • Reduced Licensing Costs by $2.5 Million.
  • Achieved Development Savings Amounting to $4 Million.
  • Ensured Uninterrupted Manufacturing Operations.
  • Avoided $1 Million in Potential Penalties.
  • Established a Fully Autonomous IT Infrastructure.

Services Offered

  • SAP Strategy
  • Program Management
  • Laboratory Systems
  • Computer Systems Validation
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Testimonial

“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

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