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In many cases we see that individuals involved in assisting with remediation have their own normal day jobs along with other duties and responsibilities. These individuals are often pulled into the project in a matrix type of organization. It is very important that commitments are obtained with the resources from the internal organization. It is important to realistically commit a resource’s time. In order to support the remediation plan, which is the top priority, we recommend the organization bring in some extra contract support. This additional support will help manage some of the day-to-day duties and offload work normally completed by key subject matter experts involved in the remediation activities. It is normally the project manager’s responsibility to make sure the remediation plan has all the proper resource loading, resource assignments, and realistic commitments.

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.

There are no hard and fast rules here. A manufacturer has to decide where certain things fit. Now, there are obviously certain accessories already identified though the classification regulations and through the product codes. So there are some things that we already know are accessories, where we don't have to guess whether ventilator tubing, for example, is an accessory. It's already identified as such.

It's a very small proportion of all of the parts that are out there are actually separately identified as accessories from a regulatory perspective. So some things we could probably look at easily and say they're not an accessory. So if we think about a replacement panel for the back of a device. Right? I think we could all look at that and go "Well, okay, that's a replacement panel. That has no effect on the performance of the device. It's a spare part or replacement part.” And on the other end, we can probably say pretty easily that something like ventilator tubing is an accessory.

In between there's this just enormous gray space. Jay Crowley, Vice President of UDI Services and Solutions and the architect of the UDI Rule says he just can't answer that question for medical device companies. You're going to have to decide by going through this process following whatever SOP you put in place and documenting this and we've used different processes with different sets of criteria, depending on the client. You're going to have to go through and decide whether something that is individually distributed is an accessory or is not. And Crowley thinks it's important to look not only at the actual words that are associated with it, but the intent of the Rule and how your customers are going to react to some things being UDI compliant and some things not.

Unfortunately, without a lot more information and understanding of your specific devices, there are no hard and fast rules here, aside from things being obviously identified as accessories already from a regulatory perspective. It's really a process and each manufacturer needs to decide how this is going to work for them.

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.

There is no single correct answer to how much data should be moved from an legacy application to the Cloud but let’s discuss the process for doing this. You will first want to look at your organization’s historical data requirements. For example, determine whether or not you will need the old data at your fingertips or if your users can look it up in the old system. Some companies maintain access to the legacy system and keep older data on it. Next, do a data quality review to determine if your historical data is clean and/or valuable. You definitely don’t want to clutter the new system with bad data. If older data is needed in the new system and it’s clean and valuable, by all means, work from a data migration plan and load it in.

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.

You do not need to communicate other areas of remediation to the FDA immediately. For instance, if you have a nine month plan and a couple months into it you find an area that you need to correct and a couple months after you find another area that you will remediate that wasn’t part of an initial finding either, you do not have to communicate all of that back to the FDA. But, in your final report or your final statement back to the FDA you may want to include that information. Including your own findings shows that you are doing your own due diligence and that you have your own internal controls in place.

USDM had a large client that had some 483s around some computer systems validation. Part of the plan was to investigate the root cause and within that was a plan to look at all of their automated systems and find out the levels of validation, if there was any validation. We found many systems the investigator didn’t look at that were not validated. We corrected the specific automated system in ERP as part of the investigation but in our final statement to the FDA we included that we addressed other areas where we found a lack of validation.

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.

There is not a requirement for full traceability like you will see in pharmaceuticals. There is a requirement for full identification through plan of use at the healthcare institutions. The distributors really don't have a traceability responsibility, they have a responsibility to ensure that only properly identified medical devices, as required by law, are continued through the supply chain.

There are specific requirements that manufacturers legislation mandates manufacturers be compliant by a certain date and those dates are already under way. For class 3 - September 2014, for class 2 and class 1 that are regulated by the sedation regulation - September 2015, with some extensions, but essentially 2015. The large remaining bulk of class 2 products - September 2016, and then the class 1 products - September 2018.

Those are the UDI Final Rule regulatory requirements. There are some exceptions for existing inventory and there are also some feature requirements for direct marking, but there isn't going to be a traceability process, such as you may see in pharmaceuticals. It will be a registration with the FDA and a identification consistent with UDI and then the ability to start adopting that as that flow starts in the healthcare institution. The legislation regulation is there, the UDI Final Rule with those dates rolling from September 2014. The product changes are on the label, the product effect is on the label, not in a transaction history or a pedigree type of traceability that's required on the pharmaceutical side.

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.

There is no regulatory requirement for direct marking the UDI on implantable devices. However, for some implants, the DM UDI will provide a way of identifying a device at the point of implantation. However, the inability to DM an implant is not an exception to the overarching requirement to provide the UDI at the point of implantation.

1. Individually labeled sterile implants

2. UDI tag – remains on the individual implant until use

3. Direct Part Marking (DPM) – 2D barcode etched on implant

4. Inventory control sheets – use sheets to map and recording sheets contain the DI in barcode and human readable lot number may be      directly marked on implant (can be recorded or photographed)

5. Mobile application – to support field replenishment – ties specific implant’s UDI to each tray/caddy and guides replenish activities

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.

A mobile device validation process should be included with your main system validation plan. It can be treated like its own mini risk based system validation with inclusion of the integrations to the parent platform or master system, such as Salesforce. Initially you perform an IQ on your hardware and software for the device using the specified operating system, hardware, and software application versions that you want to use. It’s best to prevent users from upgrading to newer versions of the operating system, but that is not always feasible. If you can’t prevent users from upgrading, you want your training policies and standard operating procedures (SOPs) to state that users are not permitted to upgrade to the newest version of operating system. You also want to make sure you do testing for the integration to the master system. You also need to consider whether data updates will be synced in real time automatically, offline manually, or a combination of both for situations when a network isn’t always available.

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.

A pharmaceutical must have the ability to be traced back to the manufacturer.  For example, authorized distributors must have information on the TH (what is TH?) TH links the product back to the manufacturer.  If there is a change of ownership between the manufacturer and the authorized distributor, the manufacturer must appear on the TH.

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.

In order to determine the rank of a supplier it is important to take the risk-based approach. The FDA really promotes that as well as what they call “the least burdensome process”. Whether it is supplier qualification, computer system validation, cleaning validation, or process validation it is essential to take that risk based approach. Evaluate the risk to the product, the risk to patient safety, and the safety's quality, identity, purity, and potency.

For example, a supplier of glass vials you will use for the final packaging of your biologics product is a much greater risk than the supplier doing your pest control. A risk-based approach will allow you to determine the risk classification. Ranking a supplier depends on its criticality to your particular function for product. You could rank them within critical or non-critical but then within each you could have various time frames as far as on site or desk audits are concerned.

Any associated activities whether it is frequency of auditing, frequency of validation, or periodic review should be scaled appropriately based on the risk. We suggest listening to the webinar on incorporating risks into the audit process. We are considered to be a thought leader in the life science industry and we are very eager to share our information on webinars.

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.

You’ve probably heard about people getting unauthorized access to a company’s data. If you have your own servers or use a third party data center, all your data resides in one place or cluster. If a security breech happens and a hacker obtains access to your systems, they can usually get their hands on all of your data. In the Cloud, your data is segmented into multiple servers around the country or even the world. Gaining access to all your data in the Cloud is much more difficult than if it were stored in one system. This means that if a criminal gains access to your sensitive information in the Cloud, they would only get a small amount of data.

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.

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