Tuesday, March 28, 2017

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.

Monday, March 27, 2017

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.

Wednesday, January 11, 2017

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.

Wednesday, January 4, 2017

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.

Tuesday, January 3, 2017

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.


Wednesday, December 28, 2016

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.

Friday, December 23, 2016

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.