Thursday, July 13, 2017

Can Data be Synchronized Between Child and Parent Record at Any Point During the Workflow Process?

TrackWise offers the option to “Copy to Child” when configuring data fields types for business process workflows, this configuration provides the flexibility to copy down data fields values from parent record into child upon creation of child record, therefore limiting users to synchronize from child to parent only. To obtain two-way synchronization functionality, TWS can be developed to synchronize child with parent records or vice versa at any point during the workflow process by pressing a button and providing users discrepancies between parent and child (useful in the case of eMDR and complaints).


USDM Life Sciences leverages an experienced delivery team, proven methodologies, and best practices validation documentation to provide our life science customers a rapid, cost-effective approach to implementing, configuring, validating, integrating and supporting your QMS.

Monday, July 3, 2017

Global UDI Database: What if a Medical Device is Discontinued?

At some point in the future when a product is no longer distributed, the medical device company will need to put a commercial distribution end date into the Global UDI Database (GUDID).  The product’s data will still reside in the database, but a flag will be set to let people know this product is no longer in distribution.  The product may still be in the supply chain and people may still own it, but medical device companies are required to add a date of when the product is no longer being distributed.

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.