So far this summer is off to a sizzling start with Innovatum managing seven global labeling UDI implementation projects concurrently. Four of these projects had their go live take place in the month of June 2015 alone! In conjunction with successfully submitting significant amounts of product UDI attribute information to the FDA Production Global UDI Database (GUDID) via Innovatum’s ROBAR Master Data Manager (ROBAR MDM) and ROBAR Communication Manager (ROBAR COM) products, Innovatum’s customers are taking advantage of Innovatum’s intensive experience with UDI implementation management. An extension of this for two major Medical Device Manufacturers is that they are now relying upon Innovatum’s expertise as a validation services provider to manage their complete validation processes.
Innovatum customers are fully exploiting the efficiencies of using ROBAR MDM and ROBAR Labeling along with ROBAR COM to deliver a system that uses one database to coalesce regulatory device and device production data throughout the enterprise and use the very same data for multiple purposes. The ROBAR product family does this while tightly managing security permissions and data access to various business departments. It makes the same data available for product labeling, can convert the data into Health Level 7 Structured Product Label (HL7 SPL) for regulatory data upload to the GUDID, and can supply product attribute data via a Global Data Synchronization Network (GDSN) certified data pool, a combination of data pools and other trading partners including “GUDID like variants” that will be required by other regulatory bodies.
According to Innovatum’s President Ardi Batmanghelidj, “Word is getting out. We have the only complete UDI management offering in the industry which includes a Master Data Management database that is the single source of truth or can get to the single source of truth. New fields can be added as requirements advance without a need for programming changes or validation. All of this data is easily tied to our industry leading medical device labeling system and/or our integrated regulatory data submissions and communication system though a few simple configuration changes. This greatly improves efficiency and reduces complexity by eliminating any requirements for duplicate approvals on the same data since one set of data is approved and then used for several purposes.” Innovatum has also announced its plans to integrate eIFU management starting in 2016 which further exploits the efficient use of this data. One of the overarching goals of Innovatum’s product set design is to minimize the involvement of IT resources required for implementation and on-going management.
The ROBAR Labeling, ROBAR MDM and ROBAR COM products maintain full audibility and are fully validatable in Medical Device Manufacturers environments with 21 CFR Part 11, 820, 830 and others. ROBAR Labeling is available separately or it can be used in conjunction with ROBAR MDM and ROBAR COM.
Enterprise Life Sciences Labeling in the cloud. It seems as if everyone wants to move to the cloud. The cloud promises many great things such as, flexibility, minimized infrastructure costs, lower maintenance costs, always being on the latest version of the software, etc. But when it comes to the labeling of highly regulated data such as within the Life Sciences (Enterprise Life Sciences Labeling), cloud based technologies can fall short in several important ways. In other words, depending upon the specific usage of cloud technology, there can be too much or too little cloud.
Enterprise Life Sciences Labeling Design
At its simplest level, labeling begins with label design. A very small ratio of people in a life sciences company have the responsibility of label design. Software products that deliver cloud based label design capabilities are inherently inferior to client computer based label design software packages. They are inferior for one simple reason. It all comes down to a lack of product maturity due to a lack of maturity of available cloud based software development and delivery mechanisms. The Internet can be used very efficiently to move graphics. However, Internet based technologies are very poor when manipulating graphics. When large manufacturers often have as few as four or five persons who need access to label design capabilities, why should they tolerate second rate cloud based label design software capabilities when it is so easy to use an industry leading label design product on the workstations of the few who need it? But as we all know there is more to enterprise life sciences labeling design than label design and design management.
Having part of your labeling data stored in the cloud and part of it stored in your enterprise systems constitutes the definition of information siloing. Since data is stored in several different places, the goal of having a single source of truth in actuality becomes having a complex understanding of the various data sources that comprise an elaborate and involved single source of truth. While complex interconnectivity between cloud and enterprise system driven data sources can be built, such systems do not offer a great deal of flexibility for the rapid changes that are required when compliance requirements change. Using the same regulatory data for multiple purposes such as product labeling, regulatory data upload to various trading partners such as the FDA GUDID, GS1 Data Pools and other trading partners as they arise offers maximum flexibility. The addition of new product attributes or the accessing of this information is much easier when you own your own data, know where it is and can get to it yourself.
Larger Life Sciences companies often have manufacturing locations in various parts of the World. Depending upon the physical location of a manufacturing plant, network connectivity, (including Internet) can be unreliable. If the data that is used for Enterprise Life Sciences labeling is stored in the cloud, and is not available at the time of production and labeling, line production comes to a screeching halt until connectivity issues can be resolved. As any of us who have experienced connectivity outages know, this is a major weakness of a cloud based label production approach.
The Hybrid Cloud
Innovatum delivers a flexible hybrid cloud model to maximize all of the benefits of cloud capabilities while minimizing the drawbacks. Enterprise Life Sciences Labeling design is client based and is built around the industry leading label design software known as BarTender by Seagull Scientific. Label approval management is accomplished through a combination of email and network technologies including options such as use of a browser through the Internet and or private networks. Label printing is accomplished anywhere in the World through the use of a browser without the need to load any software. Labeling data can easily be made highly available and is synchronized with other servers in real-time. This architecture makes it possible for manufacturing plants to print labels even while network connectivity to the outside world has been compromised. The system automatically synchronizes itself when connectivity is restored. This hybrid combination of architectures provides an ability to capitalize upon strengths and minimize weaknesses found within pure cloud based architectures.
Pulling information out of the FDA GUDID is simple. The public can access information contained in the GUDID through AccessGUDID. The FDA, in partnership with the National Library of Medicine (NLM) has announced that through AccessGUDID, anyone can search or download information that device labelers have submitted to the GUDID about their medical devices. GUDID submission options, however, is an area in which a few options present themselves.
GUDID Submission Options
#1 – GUDID Web Interface
A free secure online portal known as the GUDID Web Interface is provided by the FDA and it enables medical device labelers to enter UDI data directly into the GUDID database. Device labelers may submit, search and retrieve information about their devices via the GUDID Web Interface, which enables structured input of information one DI record at a time. A few caveats though, if data is entered using the GUDID Web Interface, it must be managed using the GUDID Web Interface. This portal is most practical for companies with <100 different SKUs or catalogue items. A number higher than that requires a more robust approach.
#2 – Software as a Service (SaaS)
The vast majority of GUDID submission offerings that are available in the market today, fall into this category. These cloud based offerings create data silos between your enterprise based systems and a third party. They also create a need for setting up and maintaining multiple connections between your enterprise systems and your product labeling systems. Introduction of errors caused by data getting out of sync between labeling and upload systems is a very real possibility. Proving auditable history for 21 CFR Part 11 compliance and potential trace history is more complex when some of the history resides in the cloud and some of it resides in other systems. In many cases, cloud based technologies have the capacity to reduce complexity. However, when it comes to regulated data upload and management, SaaS greatly compounds complexity. The outsourced service model offered by some SaaS providers is merely a way to pay a third party for some of the increased complexity that their business model creates.
#3 – Licensing A System
Systems are available from a few providers and Innovatum provides the most complete, end to end UDI solution in the industry. Although the complete suite of Innovatum’s ROBAR product line includes the option of labeling design and print management capabilities we are limiting this article to a focus on regulatory data upload. Suffice it to say that with this solution, the same database and corresponding connections to existing production and business systems (PLM, MDM, ERP, RA, etc.) can be used for both labeling data and the upload and management of regulatory data. This also means that one approval management system can be used for both labeling data approval and regulatory upload data approval. This remarkably reduces approval management overhead for medical device manufacturers and relabelers such as 3PLs and contract manufacturers. The ROBAR master data management and communication components are intended to be licensed as an on-premise solution for companies that desire tight control of their data. However, the solution can also be deployed in the cloud very easily. ROBAR MDM is a focused master data management database that is specifically designed for regulatory data. It serves as a real-time conduit for regulatory data that coalesces information from various sources and maintains the history of that data in a 21 CFR Part 11 compliant manner. The one-time licensing fee and annual maintenance costs for this technology winds up being much more cost effective than SaaS or service based per transaction, per item, per company revenue models.