Oracle Customer Success—LifeCell Corporation

LifeCell Ensures Compliance and Donor Tissue Traceability with Simplified Manufacturing Process

Oracle E-Business Suite Release 12.1.3 and Oracle Process Manufacturing have enabled LifeCell to redesign and streamline business process and ensure regulatory compliance and traceability. Oracle’s solutions have enabled us to access information at the click of a button, which helped us grow our company and speed time to market.

— Gurpreet Kaur, Sr. IT Director, LifeCell Corporation

LifeCell, founded in 1986, and headquartered in Bridgewater, New Jersey, is a leading developer of innovative tissue regeneration products for use in the reconstructive, urogynecologic, and orthopedic surgical procedures. With approximately 900 employees worldwide, LifeCell’s products are sold in the United States, Canada, and Europe. LifeCell has a number of commercial product lines used for a wide range of medical procedures including abdominal wall repair, hernia repair, facial defects, and burns.

Business Challenge

Implement a process manufacturing solution to manage the manufacturing for LifeCell’s Tissue product lines
Develop a process to easily trace products back to original tissue donor or porcine hide by transitioning processes from a completely paper tracking to a mainly online process

Re-engineer existing capabilities and “de-customize” current application by implementing a complete business management solution in order to simplify support
Expand existing capabilities and implement additional capabilities to meet increased business demand and improve usability

Simplified and standardized new product introduction with the use of Oracle E-Business Suite Release 12.1.3—improving transactional tracking and speed to market
Reduced the number of non-conformance reports by implementing Oracle Process Manufacturing—saving time and resources typically dedicated to identifying end products that fall out of compliance with government regulations

Ensured traceability back to original tissue donors and compliance to a number of medical device regulations including 21 CFR 11 for Electronic Records; 21 CFR 1271 for HCT/Ps Good Tissue Practice; 21 CFR 820 for Medical Device Quality System Regulations; AATB Standards for Tissue Banking
Leveraged Oracle User Productivity Kit to create a robust training program—reducing the amount of time needed to bring users up-to-speed on the process

Why They Chose Oracle

LifeCell chose Oracle E-Business Suite Release 12.1.3 due to its strong financial module and easy-to-use manufacturing modules. In addition, LifeCell was already successfully using Oracle for in other areas of their organization.

Oracle was very supportive throughout the process. Our overall experience was positive because Oracle helped us overcome our difficulties and we worked well as a team.

— Gurpreet Kaur, Sr. IT Director, LifeCell Corporation

Execution

LifeCell was able to quickly upgrade to Oracle E-Business Suite Release 12.1.3—including Oracle Financials, Oracle Process Manufacturing, Oracle Manufacturing Execution System for Process Manufacturing, Oracle Quality Management, Oracle Inventory Management, and Oracle Order Management—since the upgrade required little need for customization.

“We learned that it’s really important to have right level of subject matter expertise from business side from the initial phase of the project to ensure successful and robust solution,” said Kaur.