hologic customer story



Location: Bedford, MA
Industry: Medical Device
Website: www.hologic.com/
Service: Implementation


the challenge

As part of the on boarding of GenProbe, Hologic decided to upgrade EBS while simultaneously implementing Oracle Process Manufacturing.  However, Agile was implemented as a PLM system for product and document management and maintaining all FDA required documents. Their end goal was to have Agile manage the physical aspect of formulations so the DHS and DMR could be tied to the structure for reference. ZWS worked with Hologic to understand what elements of the Process for Manufacturing would be best serviced in Agile versus OPM. We decided that all transactional aspects would be best authored and maintained within EBS and have Agile maintain the physical structure and concentrations of the formula. Hologic experienced another challenge with the integration of Agile to EBS (SCMNet). The connector only supported discrete BOM and Item transfer and wasn't designed to handle formulation structures.


zws solution

ZWS worked with Hologic EBS and OPM implementation experts to decide on the appropriate data model to define and maintain in Agile.  ZWS helped develop two new classes in Agile PLM to specify formulations. First, formulas were defined to contain the structured Bill of Ingredients and describe the pertinent aspects of the formula.  The other class developed was a Process object.  This type could be classified as either Product, By-Product, or Ingredient at the BOM level.  The Formula BOM table (called the Formula Structure) was also modified to allow for correctly structuring and labeling formulations.  This included the UOM, Scale Type, and BOM Type (Product, By-Product, or Ingredient).  A process element could be defined as any one of the three depending on usage relevant to that specific formulation.  This was important since a product on one formula could be used as an ingredient on another.

The SCMNet connector also had to be modified to allow for the new formulas to be transferred to the OPM module in Oracle.  ZWS worked with both Hologic and Hitachi to elect the requirements necessary to transfer the formulations from Agile to OPM correctly.  This had to be done within 4 months, tested and ready for production


the benefits

Taking this route it allowed for all formulas to be authored and maintained within Agile PLM.  It also provided a structure that the FDA documents could be tied to enabling consistency and opening up reporting capabilities. It also allowed for the functions of process manufacturing to be maintained within Agile without having to procure and implement the Agile PLM for process application.