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.

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.

What is The Difference Between Complex Systems and Convenience Kits?

A convenience kit is one or more devices put together for the convenience of the user.  An example of a convenience kit would be a suture removal kit.  The FDA has published draft guidance that further clarifies the definition of convenience kit to limit it to those situations where everything is kept together.  A configurable system is multiple devices that come together to create multiple pieces of a system that come together to create a finished product.  A configurable system, has one or more available components or subsystems that a user can choose. The components come together at the point of installation to create the finished device.  The convenience kit has a group of already finished devices that come together to create yet a different finished device, a configurable system is a finished device, so there are various ways to assign UDI to configurable systems, understanding both the intent and the letter of the UDI rule.
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.

How does the Medical Device Single Audit Program Fit With ISO 13485? Is This Just an Emerging Program?

This emerged back in 2012 with IMDRF.  The FDA adopted it in 2014 and it can be found on their website.  It states that for the Medical Device Single Audit Program they are willing to accept audit reports as a suitable supplement for routine agency inspection.  The full implementation of this vision is still evolving.  It seems to be more focused on ISO 13485 2016 standard and some of the new case for quality might be out prioritizing this MDSAP.  If you consider the FDA’s compliance and inspection strategy they have always had a scalable approach.  In the past, it has been based more on a firm’s historical EIR experience and they would use that to determine the frequency of inspections.  This would determine whether an abbreviated inspection or full inspection would be given, and how often they would come out.  The latest case for quality initiative is a part of their evolving vision.  It does not seem as though this has reached its full implementation state at this point.  On the FDA’s website there are some testimonials about how this has helped companies to decrease the number of audits that they have done and harmonize between ISO 13485 and this MDSAP.  The participants, aside from the US, Australia, Brazil, Canada, and Japan, the world health organization and EU are observers right now.  That might be attributing to the delay. However, based on what's on the FDA website, looks like it got some momentum and that they're looking at this program to roll out in 2017 or 18.

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.

How Would a Cloud Application be Verified for a Company by USDM Life Sciences?

The USDM Life Sciences cloud hardware is qualified and our software will be on the cloud as a service. The software has been implemented with the different modules which relate specifically to the work that our clients will be doing. USDM Life Sciences will specifically go about using our validation accelerator packs that we have for each of these specific packages.  USDM Life Sciences will define a master validation plan. USDM Life Sciences will work with the clients to define their requirements beyond what has been configured as the baseline and we'll basically validate that as part of the installation qualification and operational and performance qualification.

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.

What are the UDI Compliance Activities that Typically Cause Companies Problems?

The first way we start every engagement is by getting a list of stock keeping units (SKUs): finished devices, accessories, and components put into commercial distribution in the US. That is often a difficult task as within data systems SKUs are not retired. It is not easy to tell whether your company makes that product or if your company still has that product. You will need to triangulate against a number of different systems in order to understand the different products your company distributes in the U.S. and what they all look like. Pertaining to the contract manufacturing third party, having all of the necessary conversations, determining who is going to do what, and updating contracts and supplier agreements you have, takes an enormous amount of time especially if you have 30 to 40 contract manufacturers or private labeler relationships.

Collecting all of the Global UDI Database (GUDID) attributes can also take a lot of time and energy depending on the organization. The data does not reside in one location, whatever your product labeling system is, it will not contain all the data.  It is common for some data to be in word document or excel spreadsheet. Some of the data will be site specific or corporate specific. Other data only exists on labels and therefore you must find the correct labels. So if you have not started that, what USDM recommends is that you pick a small, representative sample of your product and start collecting that data. Understand who owns the product, what the processes around it are, and what that is going to look like as you scale up to all of your products. It can take quite a bit of time depending on your organization, where the data is, and how easy it will be for you to collect, verify and normalize all of the data.

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.

Did the FDA Ever Pilot Recalls Using Unique Device Identification (UDI)?

They didn't. They didn't have Unique Device Identifiers (UDIs) in place to do a recall pilot. In fact, 2014 was when class III devices were registered and UDI compliant. In September 2015, the devices, licensing, licensing supporting and implants under the FDASIA regulations were made compliant, so there wasn't a base of devices available to do a recall pilot.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.