LifeCell Implements Software to Meet Rigorous FDA Label Tracking Requirements

Software from ClearOrbit automates workflow and labeling for processing, shipping and tracking acellular tissue grafts

Austin, Texas — March 18, 2005 — LifeCell, the Branchburg, N.J.-based developer of human-derived tissue products for use in reconstructive, urogynecologic and orthopedic surgical procedures, has implemented ClearOrbit's Gemini Simplified Interface (G.SI) and Compliance Label Manager (CLM) to automate key processes within its Oracle Process Manufacturing (OPM) module.

Because LifeCell develops, manufactures and distributes products made from human-derived tissue, the Food and Drug Administration (FDA) heavily regulates LifeCell's operations. During its product preparation processes, which are supported by OPM, LifeCell is required to record and store highly detailed data generated by its patented, multi-step operations.

To supplement OPM with trace, track and control capabilities, LifeCell implemented ClearOrbit's G.SI for OPM and CLM products. G.SI provides radio frequency (RF) mobile automation and bar code scanning of key operations within OPM to improve data accuracy and efficiency.

Compliance Label Manager provides a rules engine to facilitate adherence to FDA product labeling requirements (LifeCell manages over 130 unique label formats). CLM also includes radio frequency identification (RFID) tagging capabilities for more advanced item tracking.

Today, LifeCell said it uses ClearOrbit for direct integration to its Oracle enterprise data model to automate inbound, manufacturing and outbound shipping processes. Using ClearOrbit, LifeCell obtains real-time visibility as the company receives donated tissues (in the form of human skin), prepares the skin through highly controlled clean-room processes and ships the processed grafts for use in advanced surgical procedures.

Because of the opaque packaging used to protect the individual grafts, LifeCell implemented ClearOrbit's Compliance Label Manager to dependably match individual packaged grafts with the correct packaging components and provide multiple labels for tracking the tissue through preparation, shipping and individual surgical procedures.

"Generating custom labels as we track our products through the manufacturing and packing processes is difficult enough," said Hugh Hansard, vice president of Information Services for LifeCell," but to be able to integrate that data to Oracle Process Manufacturing without integrating separate databases was a key to our choice of ClearOrbit."

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