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.

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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.

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Innovatum Announces Cloud-Based Solutions for Regulated Labeling and Unique Device Identification Compliance

~ROBAR Online Provides Unparalleled, Scalable Security and Accessibility Capabilities~

Innovatum, Inc. has announced the availability of its highly vaunted ROBAR family of solutions for regulated labeling and UDI Compliance as a cloud based “hosted” service called “ROBAR online.” The expansion of services resets the bar for enterprise labeling capabilities and support in the life sciences industry.

The ROBAR family of products includes label design, management and printing, regulatory data management and submissions, and eIFU capabilities. Available as a single tenant solution, the ROBAR online solution includes all the capabilities and associated services that are expected from on-premise software. This includes expert consultation, implementation, integration, as well as validation assistance and on-going support.

ROBAR Online

Innovatum President and CEO Ardi Batmanghelidj said, “Through 15 years of acid testing by our customers, and as a result of our continuous improvement based on their feedback, the ROBAR on premise solution has become the leading enterprise labeling and UDI compliance software in the world. This expansion of services was made possible through diligent and dedicated efforts in managing the on premise solution for many of our customers. Along the way we embraced the growing need for cloud-based and online services, honing our skills for delivering a hosted solution regardless of its physical location. Our customer feedback has been key in providing this in-demand capability for Innovatum.”

He continued, “We are excited to bring this service to smaller companies without IT departments, and to industry leaders who feel comfortable having a world-class hosted solution.”
Innovatum is partnering with one of the world’s leading cloud based hosting companies to deliver

“ROBAR Online” in the most highly available and secure means possible. Integration with other systems such as ERP, MES and PLM remain as flexible and reliable as ever; customers always maintain access to their own data, which are not commingled with other data on the same server.

Headquartered in Atlanta, Georgia, Innovatum is a leading software and regulatory consulting company that specializes in life sciences labeling and UDI Compliance.


How Do I Shave Weeks or Months from My Software Validation?

software validationThe answer to this question is simple: have someone else do the work for you. Since there are two times (reasons) that validation is required there should be two approaches to making validation less onerous.

Software Validation Reason #1

The first reason that validation is required is unavoidable, e.g. moving to new software. But since validation is a significant effort associated with implementing any new system in a FDA regulated life sciences company, there has to be a better way than creating test scripts yourself.

Through the use of strict development methodologies such as GAMP5 with its risk-based validation approach and appropriate documentation, it is possible for a life sciences labeling vendor to pass vendor audits with excellent results. These audits, which include the review of software validation that is performed in-house is work that you will then be able to leverage to your advantage. Thus, your life sciences labeling software vendor should welcome regular customer inspections. When a company has served life sciences giants for over two decades, regular validation of their own product becomes part of their DNA.

The outcome of regularly scheduled audits should be a comprehensive validation documentation packet including: URS/FRS, functionality matrix, installation qualification (IQ), operational qualification (OQ), protocols, test cases, and test scripts for every function of the software system.

This exercise also needs to be performed whenever significant changes to the functionality of the software are introduced. Consequently, system users who have access to vendor supplied unexecuted test scripts will not have to create a validation plan from scratch. This can save hundreds of staff hours and accelerate implementation and go-live dramatically.

Moreover, the validation packet should be written by long-term veterans of the Life Sciences industry and should be successfully executed at multiple pharmaceutical, biopharma and medical device manufacturing facilities. This will ensure that the work is applicable within your company. Your life sciences labeling company should have a customer base that has been 100% successful with having their auditors accept this form of validation.

The activity and outcome that is described above should be available in two formats. The first is fully-executed test scripts in PDF form and the latter being test scripts which can be modified for your environment.

Software Validation Reason #2

I stated that the first reason why software validation is required is that the software is new to your organization and its unique environment. I went on to explain that you can make your validation less challenging by using the internal validation work of your vendor. The other reason why software validation is required is that the software has changed or the business process has changed.

While the latter is often necessary and therefore the validation is difficult to avoid, the former can be eliminated with smart software design. If part of the functionality of the software is its ability to allow user modification such as adding new fields of information for tracking (change by configuration), this functionality can be validated by the vendor. In this way, the user can make changes through configuration yet does not need to revalidate the software since the ability to make changes at the end-user level has already been validated.

Validation is considered a necessary but laborious task and the mere thought of it keeps many life sciences companies from realizing the benefits of new, good changes. It does not need to be this painful! Given the right approach, whether it may be vendor-driven validation efforts and material evidence or software that is designed in such a way that it minimizes or eliminates the need for revalidation, organizations can move on to realize the benefits of new approaches and technologies without the burdensome costs that are usually associated with them.


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.