Via The BarCode News: Innovatum Integrates Microscan Barcode Inspection Solution To Ensure Life-Sciences Quality

Microscan, a global technology leader in barcoding, machine vision, verification, and lighting solutions, will partner with Innovatum, a leading regulated labeling software and consulting services company for life-sciences, to present a fully integrated label inspection technology helping life-science manufacturers assure that all product labels are correct and barcodes meet quality grading requirements. Although scanning technologies and software for barcode verification have been around for quite some time, this fully automated closed-loop solution saves set-up time, boosts productivity of label management and inspection processes, and ensures that the risks and costs associated with mistakes and poor quality of the labels are minimized.

Innovatum will be demonstrating the integration of its ROBAR Labeling system with Microscan’s LVS-7510 print quality inspection solution embedded within a Zebra printer from the Booth #7 at the Global GS1 Healthcare Conference taking place in Chicago, IL on October 17-19. This breakthrough development is a fully automated complex solution that checks the entirety of label data to ensure data on that label is based on the information received from the Automated ID and Data Capture part of the system and is a match to the ROBAR labeling database.

To read the full article, click here.


Innovatum Makes Cover Story of Major Life Sciences Industry Publication

This month, Innovatum further demonstrates its leadership role in the Life Sciences labeling nicheregulatory data management, and submissions by contributing the cover feature article in Medical Design Briefs and an article in Medical Design Technology.

life sciences labelingAs medical technology accelerates at an almost incomprehensible pace, regulations and requirements increase correspondingly. With rapid innovation and the desire to speed time to market comes more rigorous requirements for safety and effectiveness, which drives the establishment of programs such as FDA’s unique device identification (UDI) system. UDI is designed to identify medical devices through their distribution and use in their labeling and to report certain information via publicly accessible database.

Read the full article here: http://viewer.zmags.com/publication/685a60a7#/685a60a7/12


Ensuring Quality Management Amidst Regulatory and Design Technology Changes

ensuring quality managementA regulatory driven, product design tsunami is headed our way, but at least we have an awareness that it is coming and a means of preparing for it. New requirements for destination labeling, brought about by globalization, are on a collision course with the applications of technology that we have become accustomed to. Global UDI initiatives and burgeoning breakthroughs in patient-specific modalities only add to the impact by adding to the complexity of compliant distribution worldwide. It is time to embrace a new paradigm for product design and labeling to maximize efficiency, while meeting compliance requirements for the future. While just-in-time manufacturing is here to stay, on-demand localizable labeling is quickly becoming a reality for companies that wish to remain competitive in a swiftly changing world. But patient-specific product design implies a more focused level of labeling for each unit of production. To make sense of all of this, we need to think in terms of finding a common denominator to solve these challenges. The common denominator is data.

Read the full article from Advantage Business Media.


5 Unique Device Identification Challenges

Unique Device Identification ChallengesMany of FDA’s Unique Device Identification requirements have already phased in. The labels and packages of Class III and Class II medical devices, for instance, must now bear a UDI.

“But UDI is not over,” says Ardi Batmanghelidj, President and CEO of Innovatum, a software and regulatory consulting company specializing in life science labeling and Unique Device Identification (UDI) compliance. “In contrast, it is just beginning.

“Although many medical device manufacturers have complied, on-going maintenance for previously submitted UDI data will soon be enforced,” he tells PMP News. “And the regulatory requirements of UDI variants by regulatory bodies around the world will continue to make global UDI compliance a challenge for quite some time.”

Batmanghelidj explains 5 common UDI challenges and potential solutions.

Communication. One of the challenges arises from miscommunication of labeling data. “Most medical device manufacturers inexplicably approach UDI by separating it into two different projects that are managed by two different departments,” Batmanghelidj says. “The labeling team is responsible for UDI data on the label, and the UDI team is responsible for UDI data management and submissions. Yet, most of the data overlaps and must be kept in sync! Think of a row in an Excel spreadsheet that contains fields with labeling specific data for an item. Now think of adding additional columns to house regulatory data within that same row. Since some of the data within that row is placed upon sticky labels and some of that very same data is also being submitted to regulatory bodies, this data can be stored once and reused. This ensures data quality. The problem of having to prevent a likely mismatch between the information that is submitted and the information used on the label is now gone. With an extension to what is traditionally considered to be enterprise labeling software, it is now possible to bring these capabilities to life.”

Read the full article from Packaging Digest.


Innovatum Adds Cloud-Based ROBAR Service Delivery For New Customers

Keeping with Innovatum’s commitment to deliver the highest level of customer service, we have teamed with Oracle and it’s Cloud Platform to provide easy access to our labeling solutions in a highly secure, easily available cloud environment. The Oracle Cloud Platform provides customers, partners, and developers with everything they need to build, deploy, and extend applications and run business-critical workloads.

“Our market is changing, and so must our industry-leading life science labeling solutions. So we decided to start delivering our ROBAR service via the cloud to make it easier for new customers to access our world class labeling solutions. For us, high availability, reliability and security are top priorities, especially in the highly regulated industry in which we operate,” said Ardi Batmanghelidj, president and CEO, Innovatum. “We considered several solutions, including Amazon, but chose Oracle Cloud Infrastructure as a Service due to Oracle’s reputation as a leading technology provider. Oracle’s focus on security helped to tip the scales, along with the cost-effectiveness of its offerings.”

Innovatum is well-known for keeping up with significant changes in the market and ensuring that our client’s needs our met, especially as it pertains to accessing our life sciences labeling solutions. Adopting Oracle’s Cloud Platform provides Innovatum and clients with the highest level of security and availability to its market-leading life sciences labeling solutions.

Begin a no-obligation conversation by calling 877-277-3016 or clicking here.


Innovatum, Silver Sponsor and Speaker at 3rd Semi-Annual Medical Device & Diagnostic Labeling Conference

innovatumInnovatum Inc., a leading provider of labeling management and printing software as well as regulatory data upload solutions for the medical device and life sciences market, is a Silver sponsor at the 3rd Semi-Annual Medical Device & Diagnostic Labeling Conference taking place Sept. 24-25, 2015. The two-day event is being held at the, Hilton Del Mar Hotel in Del Mar, CA.

In his case study presentation entitled, “A Unified Systems Approach To UDI” on Thursday September 24, Ardi Batmanghelidj, President and CEO of Innovatum will be discussing a software technology approach to reducing duplication of effort and leveraging labeling data along with its associated regulatory data to the utmost. Essentially, manifesting a realization of Single Source Of Truth (SSOT) theory and design as applied to the various elements that support “labeling and labeling related functions” thereby offering undeniable benefits. The discussion will include, housing data that did not previously have a good home, updating data in its primary location, eliminating the possibility of duplicates, maintaining quality data history and ensuring 21 CFR Part 11 compliance. In short, a realization of the goals of Master Data Management initiatives with re-use of the same data for various forms of regulatory upload, label management and production and also for eIFU management.

As part of its presentation, Innovatum will be demonstrating its industry leading and UDI-ready ROBAR Labeling, solution that enables end-to-end label life cycle management as well as its companion product, ROBAR MDM/COM regulatory data management and upload. The conference is set to be attended by industry leaders and will focus on a wide range of topics ranging from Maximizing Corporate UDI Strategies, Optimizing Label Translation & Content Localization Strategies all while Streamlining Label Approval Operations & Minimizing Human Errors.


Innovatum, Inc. & QuickLabel Systems Silver Sponsors and Speakers at 3rd Annual Medical Device Global Labeling Strategies Conference

3rd Annual Medical Device Global Labeling Strategies ConferenceInnovatum and QuickLabel Systems leading providers of labeling management and printing software (Innovatum) and printing technologies (QuickLabel Systems) for the medical device and life sciences market, are silver sponsors at the 3rd Annual Medical Device Global Labeling Strategies Conference taking place Aug. 12-13, 2015. The two-day event is held at the Double Tree, Hilton Hotel in St. Paul, MN.

Innovatum will be showcasing its UDI-ready ROBAR Labeling, a market-leading solution that enables end-to-end label life cycle management as well as ROBAR MDM/COM regulatory data management and upload. QuickLabel Systems will be highlighting it’s Kiaro! Fast Inkjet Color Label Printer. The conference is set to be attended by industry leaders and will focus on topics ranging from UDI compliance to regulatory data management.

Together with, QuickLabel Systems, Innovatum will also be giving a presentation on how medical device organizations can centralize the design and control of labels within a global enterprise labeling system to manage centrally and print globally.

On Aug. 13, Ardi Batmanghelidj, President of Innovatum, Inc., along with Eric Anderson, Field Sales Engineer for QuickLabel Systems, will lead a presentation titled “Designing a Streamlined Approach to Label Standardization, Development and Printing.”

Together, Mr. Batmanghelidj and Mr. Anderson will explore the topic of a global enterprise labeling system having the ability to centralize the design and control of labels to thereby ensure consistent adherence to corporate labeling standards worldwide. A close examination of capabilities that must be accounted for in system design and implementation will be discussed. The path to maximization of efficiencies and process optimization as the desired outcome will be analyzed.

 


Enterprise Life Sciences Labeling (Cloud Based)

Enterprise Life Sciences LabelingEnterprise 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.

Compliance Requirements

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.

 

 


Comparing GUDID Submission Options

GUDID Submission OptionsPulling 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.