SYSCON-PlantStar Helps Satisfy New FDA UDI Requirements
SYSCON-PlantStar, a provider of Manufacturing Execution Systems for Plastics Processing and related industries, has released advancements to its Bar Code Labeling and Traceability Modules in its suite of production and process monitoring products.
SYSCON-PlantStar expanded its offerings to support their device-manufacturing customers that must comply to the upcoming FDA Unique Device Identification (UDI) regulations. The FDA will require that the UDI on a medical device label have the product name, its expiration date, reference and lot numbers, manufacturer information, bar code, and additional details about the item. The goals of UDI labeling include improvements in product traceability, counterfeit control, electronic transaction accuracy and product information accessibility, and reduced supply chain costs.
PlantStar’s bar-code labeling feature will provide data for product traceability. “All of the product information related to a job monitored by a PlantStar system can be printed on the part label or the packaging, including the date and timestamp, product ID, shift ID, batch number, expiration date, operator ID, serial number and more,” said Townsend Thomas, President of SYSCON-PlantStar. “A pharmaceutical packaging company has greatly increased their packaging control at all of their factories by using PlantStar real-time monitoring and bar-code printing capabilities at each machine. Another of our manufacturing partners prints labels for QC inspection of injection-molded surgically implanted devices,” continued Thomas.
In addition, the PlantStar Shot Tracker software module provides enhanced product traceability. “Every bit of data related to every cycle of a machine can be stored in Shot Tracker,” said Gary Benedix, Vice President of Sales and Marketing at PlantStar. “Each cycle of data can include process variable readings, down/scrap/piece detail, material lot information and more. All this data is date and time-stamped so the medical device manufacturer has complete traceability for every cycle. The information can also be used for part/process synchronization analysis,” said Benedix. “Shot Tracker, along with our bar-code labeling software, gives a medical device manufacturer a big leap forward in meeting the FDA requirements.”
The PlantStar Bar Code Labeling software is applicable for general purpose labeling and automotive parts manufacturing as well. In addition to formats that meet FDA requirements such as ISBT128, the software also supports the Automotive Industry Action Group, General Motors, many European formats and most shipping company formats such as Federal Express and DHL. The software supports user-defined label formats to meet customer requirements.
Find out more about SYSCON-PlantStar's Bar Code Labeling and Traceability Modules.