These days, life sciences businesses dealing with global supply chains face an increasing number of important challenges. These include:
- the need to increase supply chain transparency
- the need to centralize label printing and have multiple remote printers at different geographic locations
- using automation to reduce the number of label templates
- language translation
- changing labels rapidly to suit customer needs
- providing labeling solutions in high volume
- reducing the risk of counterfeit labels
- reducing manufacturing costs
This last challenge is possibly one of the most important and an appropriate enterprise labeling is a great way to meet this challenge. An Enterprise Labeling Management System provides an enterprise class level of functionality and robustness, yet it can be scaled down to fit the smallest of organizations. Over time, you will begin to feel the pull of your growing supply chain, changing client demands and tightening government regulations. If you want to adapt to these changes with the most cost-effective solution, enterprise labeling is the way to go.
What is Enterprise Labeling?
Enterprise labeling for the life sciences industry centers around a database driven, and fully configurable computer system which tightly controls label design, rework, language translation, print and reprint and all of this can be done per 21 CFR Part 11 requirements. An enterprise labeling can save you money by reducing the waste of unnecessary stock by supporting on-demand printing as well as custom label design. The validated and automated nature of the system helps to eliminate labeling related errors that can result in expensive recalls.
Call our expert team at Innovatum today, and let’s discuss how we can help you reduce your enterprise labeling costs. We can configure a labeling solution that’s just right for your company’s needs. Let’s work together to take your enterprise labeling capabilities to the next level.
Structured product labeling (SPL) is a specific form of document markup standard, which has been approved by Health Level Seven (HL7). It is used by the FDA for the exchange of product and facility information. Continue reading
Ardi Batmanghelidj, President & CEO of Innovatum, Inc., headquartered in Sugar Hill, Georgia was selected as AIM North America Professional of the Year. Mr. Batmanghelidj has been a significant contributor to AIM’s work in healthcare and regulatory compliance, most recently serving as Chairman of the AIM NA Healthcare Committee. He is a published author and renowned industry speaker, providing expert guidance to the FDA and manufacturers in the area of master data management, labeling and barcoding. As one of the authors of the AIM white paper on UDI, he has been immersed in gauging the impact of serialization and UDI and has been assisting the industry toward compliance.
Established in 2007, the AIM North America Professional of the Year is presented annually to an individual in recognition of innovative and exceptional contributions to the development of the Automatic Identification and Mobility industry through their work as a contributor, collaborator, or mentor.
Browser-based printing solutions enable you to design and manage labels in a central location or locations and print from multiple geographic locations using only a browser. This approach delivers a number of advantages:
Product labeling is a complex process that can offer a number of opportunities for increasing efficiency and cost effectiveness. If your labeling system is outmoded, your company’s ability to meet demand efficiently is compromised. However, implementing an up-to-date enterprise labeling solution can not only streamline your operations, it can help to optimize your supply chain by ensuring that you can efficiently provide labels that meet regulatory requirements as needed and quickly bring new products to new markets.
Enterprise labeling is a term that refers to a labeling management solution which can include label design, review, and controlled revision with printing capabilities across multiple global locations. An enterprise labeling system that is designed for the life sciences must accomplish all of the above but in addition, it must comply with the provisions of 21 CFR. A Life Sciences specific enterprise labeling solution utilizes software technology that retains label data and imposes appropriate and auditable controls for compliance with government regulations to all labeling. It makes the processes of review and revision easier than ever before and reduces the risk of product recalls or other labeling related problems.
In an article titled, “3 Steps To Creating A Bar Code Labeling Niche” Innovatum, Inc. is featured in Business Solutions as an ISV that is gearing up for another year of double digit growth. Innovatum makes enterprise software systems for managing content that’s used to generate labels in FDA-regulated industries.
Automatic identification and data capture (AIDC), also known as auto-ID and automatic data capture refers to the process of acquiring data by means of electronically analyzing images, videos or sounds. The data is captured then converted to a digital representation. Several different types of technology are used to accomplish AIDC, including: Continue reading
During the course of software engineering, testing and software project management, validation refers to the process of verifying that a software solution meets required specifications. This is a formalized process and is required within the life sciences. Software validation will ensure that your software solutions comply with requirements. Failing to do so can result in your company being issued a 483. If a computer system is used to provide information to a regulatory body (such as under FDA 21 CFR Part 11), or meet requirements for the regulatory body, the system must be validated. Continue reading
A manufacturing execution system (MES) involves a computerized system that is used in manufacturing plants to indicate conditions on the plant floor and ways in which the conditions may be optimized to increase efficiency and production. Because an MES is a large, complex and varied application, there is no standard approach to implementing a MES system. Every system must be designed and customized to provide a specific solution to suit a company’s individual needs. Continue reading