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The most time consuming item in setting up an electronic Medical Device Report (eMDR) is setting up the “contract” with the FDA. First, you must sign up, create a certificate, and send it. After this, FDA will state you are ready to begin testing. The testing period involves creating all business rules in relation to the creation of the Extensible Markup Language (XML) file or the H07 file to follow FDA requirements.  Often times this process involves doing many submissions, receiving failures, and making changes until you receive a positive acknowledgement from the FDA.

The USDM Life Sciences Cloud Team is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.

There are Drug Supply Chain Security Act (DSCSA) solutions built on the EPCIS set of messaging standards being used in production. An Internet search for EPCIS will help you locate EPCIS vendors. This is not a concept that is future state. There are companies using this method every day, including some with serialized products.

Most vendors can handle EDI and EPCIS, but keep in mind the limiting factor for any of the technologies you select is whether your customer can receive the data format. According to the FDA guidance on the DSCSA, trading partners need to be interoperable – meaning they need to agree to use the same data format. Grant Hodgkins, Vice President of Track and Trace Services and Solutions at USDM Life Sciences, says the pharmaceutical industry and FDA need to partner to better define what interoperability between trading partners means.

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.

It is not a requirement; it is a recommendation. There are many advantages for using ISBT 128 for HTC/P, the most important of which is the distinct identifier that identifies all tissues from a given donor. This unique identifier allows rapid recall of products should a problem with the donor be discovered after distribution of products.

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.

After you validate the initial core platform, revalidating the entire platform as you add applications is not necessary; validation can be done on a risk-based perspective. Only the new piece of functionality must be validated. Any touch points according to your configuration managing process and risk assessment must be checked in order to ensure they have not been affected.

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 provide security, lower costs and ensure compliance.

Grant Hodgkins, Vice President of Track and Trace Services and Solutions at USDM Life Sciences says it’s unclear how this is going to work with the barcode rule intact.  At the moment, if you have a drug package that is two levels (for example, a blister pack going inside a carton dispensed at a pharmacy), the linear would continue to go on the carton as well as a data matrix.  Hodgkins says there are all kinds of variances for this particular situation and the FDA will need to clarify the requirement for this type of situation.

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.

Some of the tools you can use to help with Enterprise Content Management (ECM) implementation are project governance charts, project timelines, and responsibility matrices. Some of the other tools you can use are file sync and share solutions or anything to do with collaboration. Everything seems to be on the Cloud and externalized nowadays, so things like SharePoint 365 and VoxUltra provide external collaboration that will really help you with your implementations across any type of ECM implementation. 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.

We can all estimate times and we have all been through projects that don’t end on the date or time expected. As long as you communicate, you will be fine. If you have committed to a particular date on your 30-day response to a warning letter and you find that while you are remediating you need more time, you must communicate to the FDA. It’s not uncommon to have an initial timeline in place and then find you need additional time. You will be fine as long as you explain why you need more time, what the new time frame will be, and what the new risk factors involved are.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

Yes, they are documents. They're documents, they're processes, and they're practices that we follow. It's a set of items that you would get from USDM Life Sciences. For the following 12 months, you get the updates to all of the releases included in that VAP. It's a set of documents and a set of processes that go along with it. That can either stand-alone that you do yourselves, or you can engage us to complete them for you. Even the actual subscription piece for the 12 months, we can actually even execute the scripts that may or may not be needed depending on what's being brought up by that particular release. We can even execute them for you, so you can have a completely fire and forget compliance process for your cloud system if you want to.

The USDM Life Sciences Cloud Team is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.

There is no standard timeline for deploying an Enterprise Content Management (ECM) system. A while back, there was a CRO that was implementing an ECM system enterprise-wide and they were trying to over complicate it. It took 15 to 18 months and never got the completion on it. When the company looked back and revamped their costs to do a second attempt, they were able to do it in about three months. They decided they were going to use the DIA eTMF guidance to ensure that they could do it and just made some minor changes to the configuration. It can take up to a year, but if they use a good process it can be faster. USDM Life Sciences is working with a small company right now, and they're implementing an eTMF taxonomy in about a month and a half or so -- the work can vary. It depends on how far you want to deviate from the DIA model or if you even want to use it. Most companies choose to use the DIA model if at all possible.

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.

Generally speaking, you can’t use ISBT 128 for non-Human Cells, Tissues, and Cellular Tissue-Base Product (HTC/P) devices. There is one exception. You may use ISBT 128 for empty blood bags. We suggest people look at the Global Unique Device Identifier Database (GUDID) and Global Standards One (GS1) for anything that is not an HTC/P.

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.

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    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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