Friday, January 30, 2015

Does the UDI Extension for Some Implantable Devices Apply to All UDI Requirements?

The extension for some implantable devices does not apply to all Unique Device Identification (UDI) requirements.  The extension only applies to the label requirement.  Requirements to collect, store, normalize, validate and submit data to the Global UDI database (GUDID) must be met by September 24, 2015.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Tuesday, January 6, 2015

When to Establish Requirements for New LIMS/Lab System?

It’s important to understand the capabilities of the new LIMS and develop a baseline of requirements at the beginning of the project.  It’s a good idea to have representatives from every department that will use the new LIMS participate in establishing the baseline of requirements, because departments within a company often have different requirements.  Kathleen Warner, Vice President of Project and Program Management at USDM Life Sciences says requirements for one particular LIMS project she worked on had to be revised four times because company representatives learned about new capabilities of the lab system during the project.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.