FDA Extends UDI Compliance Deadline for Some Medical Devices

The FDA’s Center for Devices and Radiological Health (CDRH) is granting a compliance extension of some of the UDI labeling requirements for some non-sterile implantable medical devices, which were otherwise subject to the September 24, 2105 compliance deadline.The new compliance deadline is September 24, 2016 for devices that meet ALL of the following criteria:

Compliance Deadline Extension Criteria

1. classified with primary product codes and regulations listed on the letter to implant labelers
2. single use implants, and
3. intended to be sterilized (or cleaned and sterilized) before use. Most of the devices that meet these three criteria are supplied non-sterile by the manufacturer

USDM Life Sciences will provide more details about the extension at a live webinar on January 15, 2015. USDM’s Jay Crowley, who had primary responsibility for the development and implementation of FDA’s UDI system will lead the presentation.

How Much Should a Project Manager Micromanage Life Sciences Projects?

Kathleen Warner, Vice President of Project and Program Management Services and Solutions says the amount of micromanagement on projects depends on the experience level of the team.  For example, if there is a senior subject matter expert with a good track record on the team for a short term project, micromanagement of the project is not usually necessary.  Warner says a project manager should focus on delegating and facilitating tasks instead.  However, some long term projects may require micromanaging on a daily basis when you run into problems or have an approaching deadline.

USDM Life Sciences Project and Program Management experts are the perfect fit to help guide, lead and support life sciences organizations’ mission-critical project and programs initiatives across highly regulated areas, where compliance, technology and business intersect, to attain desired business results. USDM’s Project and Program Management Services and Solutions team can provide all of the required services needed to successfully manage your projects, your programs and your portfolio with consistent and standardized methods, processes and principles.

How to Research LIMS Vendors Who Understand Pharmaceutical Regulations

If you have a Legacy LIMS system, talk to your Legacy vendor.  Another good method is to search the Internet for articles that discuss LIMS.  Do a search on the Internet for “top 10 LIMS vendors in regulatory environment.”  You will be able to see some lists of current LIMS vendors as well as articles that discuss LIMS vendors.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.

UDI Label Requirements

The U.S. FDA UDI Final Rule requires all dates on labels to be in the standardized date format (YYYY-MM-DD).  The Final Rule also requires a day be specified in the date.  Dates on labels must be in the standardized format by the time the device is required to be compliant with the Final 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.

Project Management: Rules of Engagement

The best way to eliminate unwanted activities or distractions is to develop a list of “norms” at the project kick-off meeting.  The “norms” are a list of expectations of how you expect the team members to engage.  For example, if you decide you don't want instant messages or text messages as a form of communication, you make it a rule.  If you want communication to be in the form of an email, then you make it a rule.  But, Kathleen Warner, Vice President of Project and Program Management Services and Solutions says rules of engagement should be created as a team because everyone has their own best way to communicate, which should be considered as a team.

USDM Life Sciences Project and Program Management experts are the perfect fit to help guide, lead and support life sciences organizations’ mission-critical project and programs initiatives across highly regulated areas, where compliance, technology and business intersect, to attain desired business results. USDM’s Project and Program Management Services and Solutions team can provide all of the required services needed to successfully manage your projects, your programs and your portfolio with consistent and standardized methods, processes and principles.

Life Sciences Applications in the Cloud Subject to Compliance Requirements

Some life sciences applications will need to be validated when they are moved to the Cloud. Legacy applications that you have already validated would maintain their validated state. But, often times when companies move applications to the Cloud, they add additional requirements and functionalities. USDM Life Sciences often helps companies move to a cloud based Customer Relationship Management (CRM) system and access their Enterprise Resource Planning (ERP) system in the field so sales staff can handle decision making, manage trunk stock and submit orders remotely. But, if you are moving data back and forth between your cloud based CRM and your ERP system, the data most likely needs to be maintained in a compliant manner.

Ultimately, whether an application must meet compliance requirements depends on the type of data you are using in the Cloud. For example, if you need to be able to track the activity of a medical device with GxP type of data, the application you are using needs to be validated.

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.

How Long Does it Take to Implement a New LIMS/Lab System?

The time it takes to implement a new LIMS/Lab System depends on how big it is, how many users you have, whether you are going with an off-the-shelf system or a customized system.  It’s not unheard of for a LIMS system implementation to take over a year, from the time a proposal is requested to completion.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.

How to Bring a Life Sciences Project to an End

Some projects seem like they will never end.  In order to help define when a project should come to a logical conclusion, the Project Manager needs to identify the purpose, strategy (high level) and deliverables at the beginning of the project.  When a project seems like it will never end or the scope of the project keeps growing, refer back to the items you identified in the beginning of the project.  Break the project up into phases.  The items you identified at the beginning of the project can be phase one.  Newer parts to the project can be phases two, three etc. with their own purpose, strategy and deliverables.  Organizing each part of a project into phases will provide a roadmap for each part of the project to reach an end point.

USDM Life Sciences Project and Program Management experts are the perfect fit to help guide, lead and support life sciences organizations’ mission-critical project and programs initiatives across highly regulated areas, where compliance, technology and business intersect, to attain desired business results. USDM’s Project and Program Management Services and Solutions team can provide all of the required services needed to successfully manage your projects, your programs and your portfolio with consistent and standardized methods, processes and principles.

Future of UDI in Healthcare Systems

Jay Crowley, Vice President of UDI Services and Solutions at USDM Life Sciences and former FDA Senior Advisor, led a session on the future of Unique Device Identification (UDI) in healthcare systems at the 2014 UDI Conference. He noted the UDI Rule is flexible, extendable and the conceptual regulatory framework is good; however, we are all learning -- it is an iterative process. As the original legislation called for the use of device identification through “distribution and use,” there is a lot of work to be done to achieve the public benefits of UDI. The Rule was designed to evolve and grow. To improve FDA’s post market surveillance activities, the Rule’s conforming amendments mandate the UDI in adverse event reports from healthcare providers and manufacturers. So what’s next? Talk to your stakeholders, trading partners and issuing agencies about standards.

We’re listening, email us your thoughts at ComplianceSolutions@usdm.com.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet regulatory requirements, including the Drug Supply Chain Security Act, Unique Device Identification and Meaningful Use Rule.

** The FDA Amendments Act (FDAAA) of 2007 and FDA Safety and Innovation Act (FDASIA) of 2012 amended the Federal Food, Drug, and Cosmetic Act directed FDA to establish a UDI system.

FDA Will Share Data from UDI Database with Healthcare Providers

At the 2014 UDI Conference, FDA commented on their plans to share Unique Device Identification (UDI) data from the Global UDI Database (GUDID) with healthcare providers and the public. Approximately 33,000 records have been uploaded to the GUDID and once a meaningful set of data records are established (anticipated in Jan 2015), they will share through the National Library of Medicine (NLM) website where pharmaceutical label information is currently stored.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet regulatory requirements, including the Drug Supply Chain Security Act, Unique Device Identification and Meaningful Use Rule.

How do you plan to use this data? Email us your ideas at ComplianceSolutions@usdm.com.

**The world's largest biomedical library, the National Library of Medicine maintains and makes available a vast print collection and produces electronic information resources on a wide range of topics that are searched billions of times each year by millions of people around the globe. It also supports and conducts research, development and training in biomedical informatics and health information technology.

Accredited Issuing Agencies for UDI

As of September 2014, there are three issuing agencies for UDI that have been accredited by the FDA. Issuing agencies operate a system for assignment of UDIs.

The U.S. FDA UDI Final Rule indicates that not all product types need to have the same issuing agency, so medical device companies can use more than one.

Not all issuing agencies are accredited in other countries, so it’s important to review where each issuing agency is recognized if your products are sold globally.

Each issuing agency operates differently, so make sure you understand how your company would implement the standards for each agency.

FDA Accredited Issuing Agencies:

GS1
Date of Initial Accreditation: December 17, 2013
Initial Accreditation Granted through: December 17, 2016

Health Industry Business Communications Council (HIBCC)
Date of Initial Accreditation: December 26, 2013
Initial Accreditation Granted through: December 26, 2016

ICCBBA
Date of Initial Accreditation: February 12, 2014
Initial Accreditation Granted through: February 12, 2017


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.

Data in the Cloud Can Be 21 CFR Part 11 Compliant

There is no doubt about the growing popularity of cloud computing.  Companies of all shapes and sizes are moving their data to the Cloud.  One big reason for the shift is the IT cost savings.

When it comes to life science companies moving their data to the Cloud, compliance with government regulations, such as 21 CFR Part 11 and Annex 11 are a major concern.  Healthcare and life science companies need regulatory compliance to be part of their cloud solution.

Healthcare and life science companies can take advantage of the benefits of cloud solutions without compromising regulatory compliance.  There are several cloud computing providers that ensure the authenticity, integrity and confidentiality of electronic records.  But, cloud vendors are not regulated, so healthcare and life science companies need to ensure their cloud computing system is compliant with government regulations.

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 provide security, lower costs and ensure compliance.

Do UPC Barcodes Fulfill UDI Labeling Requirements?

Class I medical devices marked with a UPC barcode comply with the requirements of the U.S. FDA Final Rule. The UPC number is used as the UDI. For class II and II, it depends on whether the device contains additional Product Identifiers (PIs) on the label or package.

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.

UDI Compliance: Standardized Date Format Requirement

The U.S. FDA UDI Final Rule requires all dates on labels to be in the standardized date format (YYYY-MM-DD).  The Final Rule also requires a day be specified in the date.  Dates on labels must be in the standardized format by the time the device is required to be compliant with the Final 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.

UDI Compliance: What Format Does the Unit of Use DI Need to Be?

The Unit of Use Device Identifier (DI) must be the same format and from the same issuing agency as the Primary DI. So, if your company uses GS1 for labeling and you apply a G10 to the primary DI, then your Unit of Use DI also must contain a G10.

The Primary DI is the identifier on the label of the package. The Unit of Use DI is the identifier on devices inside the package, if there is more than one device inside. Unit of Use DIs only apply to devices subject to the Unit of Use DI.

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 Data Needs to be Included on Unique Device Identifier (UDI)?

A UDI is a unique numeric or alphanumeric code that consists of two parts:

• Device Identifier (DI): a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
• Production Identifier (PI): a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
• lot or batch number within which a device was manufactured;
• serial number of a specific device;
• expiration date of a specific device;
• date a specific device was manufactured;
• distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device

From fda.gov

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 are the UDI Compliance Requirements for Stand-Alone Software?

Stand-alone software must comply with the FDA’s UDI Final Rule.  But, there are special requirements for stand-alone software distributed virtually because there isn’t a package where a UDI label can be placed.  The UDI data must be in plain text on a “help” or “about” screen.  Software distributed on a CD, DVD or USB flash drive must have a UDI on the label of the device.

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.

Do Manufactured Parts for Medical Devices Need a UDI?

If you are manufacturing and selling a part of a medical device to another manufacturer (not a complete device), the package does not need a UDI.  However, the fully assembled device will need a UDI for distribution.

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 Lancets Included in the UDI Final Rule Single Use Packaging Exception?

Single use lancets are included in the single use packaging exception.  A single use device is not required to have a UDI on the package if it meets the following criteria:

• Device is distributed inside a package with more of the same devices. (The package that contains multiple single use devices is required to have a UDI.)
• Device is intended to be stored in the package with more of the same products until use
• Singe device is not intended for distribution
• Device is not considered an implant by the FDA

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.

UDI Compliance: What Does a Medical Device Manufacturer Do With Devices Already Distributed?

The FDA’s UDI Final Rule is not retroactive, meaning it does not apply to devices that were distributed before the compliance deadline.  However, existing inventory (at manufacturing site, distribution center or on consignment) needs to be sold or comply with the UDI Final Rule by September 24, 2017.

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 Do I Know if a Class II Device Needs to be UDI Compliant by September 2015 (FDASIA) or September 2016?

Medical devices classified as implantable, life-saving and life-sustaining by the FDA must be UDI compliant by September 24, 2015.  The FDA lists every medical device by product code that must be UDI compliant in 2015 on this list.  If the class II medical device is not on the list, it does not need to be compliant until September 24, 2016.

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.

UDI Compliance: How Do I Know if My Kit Can Take Advantage of the Convenience Kit Exception?

If you place a UDI on a kit, you do not need to place a UDI on the components in it. However, the manufacturer still needs to have traceability of the components in the kit with the UDI. If there is a problem, the company must know which devices are inside the kit, so it knows which kits to recall. Although this is a UDI exception, medical device manufacturers still need to maintain control, visibility and traceability of the components with the UDI on the kit.

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.

UDI Compliance: How Does the Single Use Device Packaging Exception Work?

A single use device is not required to have a UDI on the package if it meets the following criteria:

• Device is distributed inside a package with more of the same devices. (The package that contains multiple single use devices is required to have a UDI.)
• Device is intended to be stored in the package with more of the same products until use
• Device is not intended for distribution
• Device is not considered an implant by the FDA (Check this list to see if the FDA considers your device an implant.)

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.

UDI Compliance: What Parts of a Medical Device Need a UDI?

Any individual accessory or component that a manufacturer puts into commercial distribution must have its own Unique Device Identifier (UDI).  Spare parts for devices do not need a UDI.  An important part of the UDI compliance process is to determine which components and accessories are spare parts and therefore do not need a UDI.

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.

UDI Compliance: What is a Unit of Use DI? When is it required?

The Unit of Use Device Identifier (DI) is a requirement of the Global UDI Database (GUDID).  A Unit of Use DI refers to a product within a package that is not marked with its own Unique Device Identifier (UDI).  For example, an individual bandage in a box of 10 will need a Unit of Use Identifier.  When you submit data for the box of 10 bandages to the GUDID, you will be required to submit a virtual identifier called the Unit of Use DI for each bandage.  Because the identifier is virtual, you are not required to physically place a Unit of Use DI on each bandage within a package.  The Unit of Use DI is a method to discuss, describe and document a single bandage in the GUDID.


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.

UDI Compliance: Do Class I Medical Device Manufacturers Need to Do Anything Yet?

Class I medical devices don’t need to be UDI compliant until September 24, 2018. Jay Crowley, former Senior Advisor for Patient Safety in the FDA’s Center for Devices and Radiological Health and Vice President of UDI Solutions and Services at USDM Life Sciences, encourages manufacturers of class I medical devices to begin to understand UDI compliance and start to put a plan in place.

Many class I medical device manufactures will need new computer systems or additions to Product Lifecycle Management (PLM) and Product Information Management (PIM) systems. The selection and validation process for new systems can be time consuming.

Medical device manufacturers that distribute class I products outside of the United States should consider meeting the UDI compliance deadline early because some countries will require UDI compliance before the U.S.

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.

Exceptions to the UDI Compliance Deadline

Medical device manufacturers can ask the FDA for an exception to the UDI compliance deadline.  Several medical device manufacturers have asked for and received an exception because of compliance difficulties.  Any exception to the UDI deadline requires the medical device company to have a compliance plan and date of when the company plans to be UDI compliant.

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.

Drug Supply Chain Security Act (DSCSA): Are the Required Data Elements in the Data Matrix for 2017 Consistent with Previous Guidance Document on SNI?

The data elements are consistent with Standardized Numerical Identifier (SNI).  SNI guidance discussed GS1 standards by stating you can use GS1 standards to generate what the FDA considers an SNI.  The DSCSA refers to SNI in the draft guidance, which is a direct reference to SNI guidance from 2010.  On another related topic that sometimes causes confusion, the SNI guidance allowed for additional attributes to be encoded in the barcode if desired (such as Lot and Expiry), there is no conflict at all between the SNI guidance document.

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of 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 foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Drug Supply Chain Security Act (DSCSA): What Deadlines Occur Between 2017 and 2023?

Requirements for wholesale distributers, repackagers and pharmacies will take effect on a staggered basis between 2017 and 2023.  There aren’t many requirements for manufacturers after 2017, except to work with the FDA and the rest of the industry to figure out what will happen in 2023 with the shift to a new type of security system. However, as a practical matter, there will likely be a lot of work done to continue to improve and streamline all these new processes, adopt additional automations, and begin preparations internally to do the necessary implementations that are coming in 2023.

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of 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 foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Drug Supply Chain Security Act (DSCSA): How Do I Parse Data from Barcodes to Pull Only the Data I Want to Capture?

In the GS1 standards, there are very specific rules that help you determine how to parse the data that you want to capture into your information systems. For example, if you wanted to only capture the GTIN and Serial number but the barcode carried the Lot and Expiry also, you would scan the barcode, capture the entire data string, use the GS1 General Specifications to determine which Application Identifiers (AI) carry the desired data, determine how the string of data is terminated for each piece of data, then apply that logic in your information system to select only the data elements you wish to capture. Some AIs are fixed length, some are variable length. The variable length AIs are terminated either using a ‘separator character’ such as a Function1 or the end of string character (when that AI is the last AI in the string).

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of 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 foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Does the Drug Supply Chain Security Act (DSCSA) Have Guidance for Requests for Verification?

The guidance does mention creating a system for manufacturers to respond to verification requests. But, there is no specific mention of what “system” means.  System may simply mean standard operating procedures or business processes. To be clear, it does not necessarily mean ‘computerized system’. The verification process in the short term may look like the processes used to fulfill the Florida ePedigree requirements.  In those situations, the verification process involves phone support from the manufacturer, and the manufacturer has an internal capability to access information quickly without relying on an IT analyst to create and generate report data.

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of 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 foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Does the Drug Supply Chain Security Act (DSCSA) Support Product Returns and Resales?

When a wholesaler receives inventory returns from a pharmacy for credit, a wholesaler can determine whether the product is still saleable.  As long as there is nothing wrong with the product, the wholesaler is able to resell the product.  But, wholesalers (starting in November 2017) must submit a request for verification from the manufacturer.

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of 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 foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Drug Supply Chain Security Act (DSCSA): What Data Exchange Formats Will be Acceptable to Trading Partners?

Electronic Data Interchange (EDI) is the most commonly accepted electronic data exchange format by trading partners. Electronic Product Code Information Service (EPCIS) is another electronic format.  However, it appears that only a small number of companies will use EPCIS.  You should consider whether large wholesalers are willing to accept EPCIS before deciding on a data exchange format.  Not all large wholesalers have indicated they will accept EPCIS.  Another option to consider is an electronic invoice, which is an electronic method of transferring data from an invoice.  But, wholesalers may try to dissuade you from using electronic invoices to carry data such as lot numbers, transaction statements and other data required by the DSCSA due to complexities of pulling that data out of this format for further use.

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of 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 foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Drug Supply Chain Security Act (DSCSA): Is Aggregation Necessary?

Aggregation is not an explicit or implied requirement of the DSCSA. There is no requirement forcing companies to know which serial numbers are inside a particular case. However, aggregation does have non-regulatory value to manufacturers. What makes aggregation controversial in the DSCSA is the term “verification.” What does “verification” mean, how is it going to be interpreted in future FDA guidance, and how is it going to be interpreted by customers? One question that remains unanswered is if a customer receives a case of a product along with serial numbers for each item in the case and later it is discovered that one of the listed serial numbers is not in the case, are they somehow liable because of the term “verification”?

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of 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 foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Do Medical Device Parts Need a UDI?

A commercially distributed part of a medical device does need a Unique Device Identifier (UDI).  Parts for medical devices used for repairs that are not commercially distributed do not need a UDI.

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 Long Does it Take to Upload Files to Global UDI Database?

If you are using the GUDID Web Interface, it will take 10-15 minutes to enter all the data for one device identification record.  However, proficient users would likely be able to enter the data faster.

If you are using the SPL submission method, updates to the GUDID happen nightly.  So, if you submit a record today with a publication date of tomorrow, the record will be available on the GUDID tomorrow.

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.

Methods to Submit Data to the Global UDI Database

Web Interface:
The GUDID Web Interface supports submission, search and retrieval of device information through a secure web interface.  In order to submit device information to the database, you must first obtain a GUDID account.

SPL Submission:
SPL submission allows companies to electronically submit device information one device identification record at a time with an HL7 SPL XML file.  In order submit data using SPL submission, you need to create a GUDID account and use the FDA Electronic Submissions Gateway.  Companies will be required to complete GUDID testing prior to production submissions.

Spreadsheet Uploads:
Some of USDM Life Sciences’ UDI application partners have tools that enable data from spreadsheets to be uploaded to the GUDID.  Contact USDM Life Sciences to learn more about what GUDID submission solution is best for your company.

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.

Global UDI Database: What if a Product is Discontinued Before the UDI Compliance Deadline?

Data for a medical product that will be discontinued before the UDI compliance deadline is not required to be entered into the Global Unique Device Identification Database (GUDID), it is optional.  You can enter a begin distribution date and an end distribution date of today into the database.  You may want to add a product to the database that will be discontinued if the product has a long life or a long supply chain so the record exists in the database.

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.

Global UDI Database: What if a Medical Device is Discontinued?

It 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.

Global UDI Database: What Verification or Validation Does FDA Need?

There aren’t any validation activities beyond what the database is doing inherently or through business rules.  There is no formal review of device data by FDA auditors or inspectors.  FDA does have a team of data quality experts who examine whether the instructions are clear and ensure data is coming into the database in a consistent manner.  Ultimately, FDA employees are looking to make sure the database is operating correctly.

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.

Benefits of Pharmaceutical Serialization

The Drug Quality and Security Act (DQSA) was enacted on November 27, 2013. The DQSA calls for a 10 year implementation plan to track pharmaceuticals as they make their way from the manufacturer to a pharmacy.

But, there is more to the serialization regulations than compliance. Pharmaceutical companies will gain many internal benefits by adopting a serialization system.

Product Authentication 
Serialization can prove a products authenticity, which means a manufacturer can detect and combat counterfeit products and ultimately protect their company brand.

Coordination of Supply Chain Data
Manufacturers can get information about products as they move through the supply chain. Supply chain visibility can help a company control inventory and reduce costs. Manufacturers can also see the impact of supply chain disruptions.

Efficient Recall Process
Manufacturers can conduct precise recalls by pinpointing locations that received the product in question.

Grow Revenue 
Reduce counterfeit activity that occurs when products are faked and diverted.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of 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 foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

The Drug Quality and Security Act (DQSA) Will Hopefully End Counterfeit Medicine Problem in the U.S.

One goal of the Drug Quality and Security Act (DQSA) is to prevent counterfeit pharmaceuticals from getting in the hands of unsuspecting people because many of them don’t have the correct ingredients in them.  In fact, some of the ineffective medicines contain unsafe ingredients.

In January 2014, two people were charged with shipping fake cancer drugs to the United States, some of which authorities say were only vials of water and mold.

In February 2013, the FDA found a product labeled as an injectable cancer medicine, but there were no active ingredients in it.

In 2012, the FDA warned consumers about a counterfeit drug to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy.  The FDA’s laboratory tests concluded the counterfeit version of the drug contained the wrong active ingredients.  Instead, the pills contained ingredients to treat pain.

The World Health Organization estimates that up to 10% of the pharmaceutical market is fake, much of it can be found on illegal websites that hide their geographic location.

The DQSA was signed into law by President Obama on November 27, 2013, which means pharmaceutical companies will be required to adopt an electronic system to identify and trace their medicines as they make their way from the manufacturer to a pharmacy.  Some of the requirements of the DQSA start on January 1, 2015.  Read more about the implementation timeline here.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of 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 foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Drug Supply Chain Security Act (DSCSA) Implementation Timeline

The Drug Quality and Security Act (DQSA) was enacted on November 27, 2013.  Title II of the DQSA is the Drug Supply Chain Security Act (DSCSA).  The enactment of the DSCSA started the clock on a 10 year implementation plan to track pharmaceuticals as they make their way from the manufacturer to the pharmacy.

There are many activities described in the law that need to happen during the long implementation process that FDA will oversee.  Everything from guidance and assessments to regulations will be issued from FDA on a staggered basis between now and approximately the year 2024.  The DSCSA also requires many public meetings where stakeholders will be able to give their input on what will become the final regulations.  Below is an overview of the timeframes for the DSCSA.

from FDA

Sales of Counterfeit Drugs on Rise

Getting a prescription filled at a cheaper online pharmacy is tempting for many of us.  But, if your online pharmacy is not verified, there’s a chance you are being ripped off or worse yet, putting your life in danger.

The World Health Organization reports that in more than 50% of cases, medicines purchased over the Internet from illegal sites that conceal their physical address have been found to be counterfeit.

In many cases, the drugs do not have their intended ingredients in them. Patients who unknowingly obtain and use the counterfeit drugs are not getting the medical treatment they need and many unsuspecting patients are dying from the counterfeit medicines.

A federal track and trace bill was recently signed into law. The law, known in Congress as the Drug Quality and Security Act means pharmaceutical companies will have to adopt a track and trace system for their medicines.

Individual packs of drugs will need serial numbers within four years of the bill becoming law, which is November 27, 2017. In 10 years, medicine will need to be traceable as it makes its way from the manufacturer to a pharmacy.  Countries in other parts of the world have already implemented similar regulations.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our track and trace team 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 foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

Data Encryption Key to Cloud Security

The most effective way to maintain data security is with data encryption.  Data encryption is the process of turning data into a secret code so third parties can’t read it, unless they are authorized.  Data is usually encrypted using an algorithm.  Any unauthorized party who sees the data won’t be able to determine its contents without an encryption key, which many of us refer to as a password.  If someone does gain unauthorized access to your data, encryption will ensure it is not readable.

A critical part of data encryption is encryption key management.  Secure key management solutions are the only way to use the Cloud securely and maintain compliance with government regulations, such as HIPAA.

USDM Life Sciences specializes in providing answers and solutions for life science companies looking to move their software and servers to the Cloud.  For more information, visit our Life Sciences Cloud page.