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.

How Does a Company Decide What Data it Wants in its Salesforce Org from the GUDID?

USDM Life Sciences can help a company import their existing device data, such as internal data or data from Global UDI Database (GUDID), into the UDI Connect objects within Salesforce. After deciding which types of devices will be included on the application, it is part of USDM’s implementation process for UDI Connect to ensure all of the client’s desired data is in the system. It is also possible to use USDM’s hosted GUDID database to bring in specific device data to UDI Connect.

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.

If a Device Does Not Require DM, is it Acceptable to Only Have the UDI on the Package Label?

The Unique Device Identification (UDI) must always be carried on the product label - so it depends on whether the information on the device constitutes a label. The Direct Mark (DM) requirements only come into play if your device meets the criteria for direct marking.

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.

Are Salesforce Patches Pushed Directly to Production or Can Changes Be Tested First?

Salesforce.com patches are pushed directly to the production environment, unlike releases. You get informed of what they are and what they affect.

The patches have already been tested to make sure they don’t affect specific configurations. Typically, they do not affect anything internal from your own configurations as well. But, it is best to analyze the patch and determine whether to regression test it.  Patches can be regression tested very quickly, especially if you have an automated tester. For most patches, it is possible to determine using your change control processes that they have no effect on anything preexisting.

USDM Life Sciences specializes in providing answers and solutions for life sciences companies looking to move their software and servers to the Cloud. In fact, many of the largest software and hardware companies in the world come to USDM Life Sciences for best practices in the Cloud.  As a recognized global leader in life sciences compliance, USDM Life Sciences Cloud Solutions and Services.

What Types of Cloud ECM (Enterprise Content Management) Systems Are Available Right Now for Clinical Solutions?

There are a few cloud based ECM products out there. Alfresco provides cloud-based usage solutions that are smaller, more scalable solutions. Escort Viva is a giant in this space; They have been the front runner and have been providing a compliant cloud solution. Box and Drop Box provide cloud-based ECM solutions, but they are not Part 11 compliant and do not follow GxP standards at this point, will in the future. Ideally, once they are compliant, they can be used for business operations.

The USDM Life Sciences Clinical Services and Solutions team provides our clients (from start-up Biotech to large Pharma/Device) with the latest technology, processes and strategies to assist with efficiency, quality and compliance in any scenario and offers our clients a cost-effective, proactive and unified partnership in goal achievement.