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Medical Device Manufacturer System Migration to SAP and Automated Workflow Overhaul

A Medical Device Manufacturing industry leader, representing advanced levels of solid-state liquid and semiconductor technologies was spun off by their parent company requiring them to establish a new IT infrastructure and migrate from Oracle and Agile to SAP PLM.  The company produces, develops, and manufactures a diverse range of leading treatment applications for hair removal, skin revitalization, scar reduction, gynecological health, body contouring, and more. Their products are used worldwide by practitioners, physicians, and aesthetic business owners to help enhance their offerings while providing the latest treatments to patients.  The company is constantly looking forward to staying one step ahead of the industry and its engineering processes are key for them to maintain its competitive advantage. The company works in a heavily regulated industry which requires strict control processes and data management, so they turned to LeverX for help.

Challenge:

FDA regulations, including compliance with CFR 21 Part 11 requirements, created pressure for accurate record-keeping that would withstand government audits.

The migration of data from multiple systems, including Oracle Agile PLM. Data needed to be extracted from the legacy systems and transformed for import into SAP. The key challenge was to ensure that proper records and history were imported that would stand up to audit challenges.

There was a significant learning curve for client employees to understand the nuances of SAP vs their former Oracle and Agile systems. Users were coming from a very mature systems environment with advanced capabilities having been built into the systems over years of development.

The company desired to consolidate its IT infrastructure into a single ERP system.  It was identified during discovery that the workflows the company wanted could not be supported by SAP base functionality.  They needed more flexibility to manage their business processes driven by strict government regulations.  Furthermore, the company wanted to continue its operating procedures and practices to maintain consistency.

 Solution:

LeverX partnered with another integrator to migrate all of the company’s processes to SAP.  LeverX focused on the Product Lifecycle Management (PLM) capabilities along with workflow enablement of key quality management processes including CAPA, SCAR, deviation, and others. The partner focused on the core ERP functions, including manufacturing, sales, and finance, and related migration pieces.  

LeverX implemented core SAP PLM functions which included data management processes for materials, Bill of Materials (BOM), document management, engineering changes, material classification, and workflow enablement of key processes.

Quality Management tickets were introduced to address quality monitoring processes.  (Corrective action preventative action tracking, Supplier corrective action requests, deviation tickets that allowed some standard deviation for the materials they tracked, health hazard evaluation, and field actions)

LeverX Integrated Process Solution (IPS) integrated the company’s processes end to end to address the unique workflows that were required due to regulation, and also gave the company’s end-users the flexibility to make changes on the fly.

BOM / Material Master Extension & Allocation Tool (BMAX) automated the processes to migrate all of their materials, set up the new Material Master processes, and build extensions in the new ERP.

Velox extracted data from multiple disparate sources and migrated them into the new system.

Cideon Conversion Engine converted all of their paper documentation into pdfs and gave them the ability to stamp for approvals.

Results:

LeverX successfully centralized multiple disparate systems managing key product data into a single SAP PLM for data and process management.  If not for LeverX’s IPS product, the company would still be reliant on manual processes and submitting paper documentation versus submitting documentation electronically. With a good base now in place, the company is now moving on to the next phase items which include enhancements, additional guard rails to ensure the process integrity, and reporting/metrics.