Error-Proof Manufacturing for Life Sciences Innovator

About the Customer

A North American pharmaceutical manufacturing leader with production sites around the world, the customer specializes in preclinical and clinical laboratory, gene therapy and cell therapy services for the pharmaceutical, medical device and biotechnology sectors. The customer is committed to delivering innovative products and services that help expedite the discovery, early-stage development and safe manufacture of novel drugs and therapeutics.

Customer
Pharmaceutical Manufacturer
Location
United States
Industry
Pharmaceuticals & Life Sciences
Siemens Opcenter Execution Medical Device & Diagnostics

Challenge

The pharmaceutical manufacturer wanted to move to paperless manufacturing and improve throughput, quality and real-time visibility at its flagship U.S. site but needed guidance to select the right MES platform and define clear business and technical requirements.

Solution

IndX led the vendor selection and requirements workshops, then implemented Siemens Opcenter Execution Medical Device and Diagnostics with Electronic Batch Records and integrated it with the existing SAP ERP system to deliver a full-scale MES supporting real-time production, material and quality data management.

Project Activities 

  • Supported MES software vendor selection process to identify best solution for the customer’s unique needs.
  • Chosen as implementation partner for Siemens Opcenter Execution Medical Device and Diagnostics (MDD) solution integrated to ERP system.
  • Led analysis workshops with key stakeholders for business and technical requirement definition of future solution.
  • Delivered full-scale MES solution enabling production resource, process, material and quality compliance data management and monitoring in real time.

Business Drivers 

logo
Improve throughput and time-to-market
logo
Accelerate quality assurance processes
logo
Eliminate inefficient paper-based processes
logo
Increase automation of production in the future
logo
Gain real-time visibility across production process
logo

More About the Project

As a provider of leading-edge solutions, the customer recognized the potential for huge time, cost and quality savings in their manufacturing process through the implementation of digital solutions for Manufacturing Operations Management (MOM). Although they knew what they wanted from the solution, the customer did not know what software product would best meet their business requirements. As a well-known expert in the delivery of digital manufacturing services and Industry 4.0 technologies in North America, IndX was brought in to advise the customer on best practices when selecting software for operational optimization.

After collaborating closely with key stakeholders across the organization, our specialists helped the customer define a set of technical and business requirements that the future MES solution would have to meet to be considered successful. Among these requirements were that the MES product selected would enable ease-of-use for operators, its capabilities could be scaled across sites in the future and the solution would guarantee a return on investment.

We provided consulting services throughout this process in order to help the customer identify Siemens Opcenter Execution MDD as the right technology in terms of functionality and flexibility. Additionally, our specialists were selected as the top Siemens MES implementation partner to develop and deliver the new solution and integrate it with the customer’s existing SAP ERP system.

IndX’s Advantage

As a longstanding partner of Siemens Digital Industries specializing in their MES portfolio, as well as an established system integrator in the Industry 4.0 space, IndX was the right strategic partner to help this pharmaceutical innovator digitalize their manufacturing operations, ensure quality and patient safety and take their business to new levels of efficiency. We continue to support the customer on their digital transformation journey, delivering new system integrations and solution improvements based on feedback.

Tripti Dutta

NA Delivery Lead, Serialization
Tripti brings over 18 years of SAP experience, including 11 years specializing in serialization and track & trace implementations across regulated industries. At IndX, she leads North American delivery for serialization programs, with deep hands-on expertise across SAP ATTP, AII/OER, ICH, TraceLink, and ABAP-driven integrations, owning execution from regulatory requirements through production rollout.
talk with our experts
image

Start Your Digital Thread With IndX

Fix execution at the source

When engineering, manufacturing, supply chain, and analytics run on disconnected data, problems compound downstream. IndX helps you establish a controlled digital thread that turns intent into reliable execution. Start with a free assessment call.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.