Atlanta, Georgia  11/15/2022

Banyan Software, Inc., a company focused on acquiring, building, and growing great enterprise software businesses, is excited to announce the acquisition of Innovatum. Innovatum’s enterprise labeling software solutions enable the automation of product and package labeling and regulatory data upload in the life sciences industry.

Innovatum’s flagship product suite, ROBAR, organizes and streamlines the entire labelling process for life science manufacturers, including design, printing, auditability and regulatory compliance. These agile and fully configurable solutions deliver process efficiencies, unlock savings, and reduce risk by enforcing compliance in an evolving global regulatory environment.

“Innovatum has an impressive track record of delivering enterprise-scale labeling software solutions for its customers worldwide,” says David Berkal, CEO, Banyan Software. “We were impressed by the innovative and customer-centric culture established by the team. I’m excited about Innovatum’s journey onward as we continue to invest in the business and enable it to play a key role in ensuring the integrity of the global life sciences supply chain.”

“As founders of a company that we have nurtured into a best-in-class offering, it was critical for us to find an acquirer like Banyan. With its proven buy-and-hold philosophy, I’m confident in a seamless transition and that we’ve found the right long-term home for our two cherished constituencies — customers and employees. I’m thrilled by the notion of working with Banyan for the foreseeable future to further accelerate the organic growth of Innovatum while maintaining our extraordinary level of support and service,” says Ardi Batmanghelidj, CEO, Innovatum.

About Innovatum.

Innovatum is a regulated labeling software and consulting services company; a prolific innovator in its industry, tightly focused on life sciences labeling for more than two decades. As regulatory compliance experts, Innovatum provides specialty, configurable labeling software to fit the needs of its global customers. Innovatum has championed many of the most significant innovations in the industry. For more information, please visit: https://www.innovatum.com/

About Banyan Software, Inc.

Banyan Software provides the best permanent home for successful enterprise software companies, their employees, and customers. With a permanent capital base set up to preserve the legacy of founders, Banyan focuses on a buy and hold for life strategy for growing software companies. Founded in 2016, Banyan is backed by a world-class group of CEOs and investors with deep technology experience and currently operates across a growing number of verticals. For more information, please visit: banyansoftware.com.

SOURCE Banyan Software, Inc.

Destination Labeling, also known as Local Language Labeling, Just-in-Time labeling, Regionally Specific Labeling, etc. addresses the challenges that most manufacturers in the life sciences industry are presently struggling with.

Having great solutions for these labeling challenges is one thing, conveying the concepts is another. That is why Innovatum has produced three short new videos. This first video describes our DL solution.

On December 14, 2020, the EC outlined rules for electronic IFUs. The question now becomes . . . what are the implications of this?

Simply put, taking advantage of the cost savings and risk reduction inherent with moving to eIFUs involves two primary areas of consideration. Specifically:

1. Delivery of the eIFU service itself and . . .
2. Delivery of the labeling related changes that must coincide with other changes.

Delivery of the IFU

Pre-launch activities involve:

• Planning
• Reviewing internal quality procedures
• Risk Assessment
• Implementation
• System Validation

Providing quality on-going eIFU services involves:

• A multilingual website interface and multilingual phone services provided worldwide that is free of charge for callers.
• Delivery of paper based IFUs free of charge to requesters within 7 days of request.
• Archived eIFUs in some cases, being made available for a periods of up to 15 years.
• Maintaining a system to clearly indicate when the eIFUs have been revised and it must inform each user of the device if the revision was necessary for safety reasons.
• Verifiable levels of security and high availability for the eIFU hosting website.

Delivery of labeling changes

The associations between products requiring an eIFU, the versions of eIFUs and also patient facing information must be managed. This endeavor includes the translations of various languages and the replacement of existing versions of electronic documents. And this occurs whenever new documents have been created, reviewed, approved and readied for posting. Multiple documents may need to be related to the same products and printed at packaging time. Also, changes must be made to actual product labels to indicate that an eIFU is available. A strong Destination Labeling component has the ability to tie everything together and accomplish all of this nicely through automation.

The ROBAR system by Innovatum with its associated delivery and support services eases the transition to eIFU. Associations between products, various IFU and eIFU versions, languages and on-going histories of prior versions are stored in the ROBAR Master Data Management database. This is exactly what is needed for accurate and efficient Destination Labeling. Data is used to update hosted web based systems to ensure that the most current, approved, version specific, language specific and historically tracked information is made available appropriately.

As a contributing member of AIM, Innovatum invites you to take advantage of this free 2-hour UDI Masterclass we sponsored that was conducted by FDA and noted industry experts including Jay Crowley and Terrie Reed.

The Seminar recording is now available along with the session slide decks.
https://www.aim-na.org/udi-work-group.html

UDI SEMINAR TIMESTAMPS
1:41 – Unleashing the Potential of Medical Unique Device Identification | James Tcheng, Duke University Health
28:17 – Challenges with UDI Implementation | Jay Crowley, USDM and Dennis Black, BD
55:48 – UDI Panel – Vision and Reality | Patti Blessing, CAVU; Terrie Reed, Symmetric; Natalia Wilson, Arizona State University; Olga van Grol-Lawlor, Boston Scientific

Regulatory bodies, device manufacturers, healthcare providers and numerous other stakeholders are gearing up for global implementation which presents its own specific challenges and opportunities. Adherence to specific regulatory specifications, both in labelling and packaging as well as data is a must, but in an increasingly competitive market, achieving compliance while maintaining a competitive edge and assuring ROI is paramount. This recorded Seminar highlights the state of urgency in the industry, addresses implementation challenges – plus helps you to maximize the ROI of your UDI implementation in the future, ensuring it continues to drive business value.

A joint case study presentation “CONSIDERATIONS FOR END-TO-END LABELING IMPLEMENTATION & OPTIMIZATION” by Aimee Wright- Labeling Manager, Global Labeling Zimmer Biomet and Ardi Batmanghelidj- President and CEO.  The session conveys real-world scenarios and covers topics such as:

• Comparing varying perspectives into end-to-end labeling
• Needs assessment: Full implementation versus upgrade
• Technology solutions & related cost considerations
• Common execution missteps & lessons learned