eLabeling
Superior Software Extraordinary Support
eLabeling (electronic labeling) streamlines processes, increases efficiencies, and reduces costs. A complete eLabeling system can be difficult and expensive to build, maintain, and validate, but Innovatum makes the integration and delivery of eIFUs easy and cost effective.
Select Customers
eLABELING With ROBAR
Complete Automation
All relationships between products (items), their versions, eIFU documents, and their language translations are stored within the ROBAR database. This information is then used by ROBAR to provide complete automation for eLabeling.
21 CFR Compliance for an eLabeling System
21 CFR compliance requires all systems that interoperate with the eIFU system to be 21 CFR compliant themselves. ROBAR labeling is 21 CFR compliance capable once validated for your specific environment.
A Quality Driven Approach
The ROBAR labeling system automatically ties IFUs and eIFUs to the lot level, manages versions and make the most current eIFU version appear on provider facing and/or patient facing websites.
Overcoming eLabeling Challenges
The ROBAR solution connects your company and its customers to a toll-free phone network that is staffed 24/7 with multi-lingual persons who are capable of speaking with medical professionals across several countries.
Validation Made Easier
Business risk analysis services and almost 1,000 pages of validation documentation help prove that website and freephone service are compliant with applicable regulations. This includes security requirements and system availability.
eLabeling Training
Incorporating the use of an eIFU system requires training. Since the addition of eIFU management and delivery capabilities is modular, training for this system is available as needed.
Comply with Regulations As They Grow
Compliance with the EU, FDA, and the regulations of other regulatory bodies will require on-going dedication and specialization. Outsource your eIFU management and delivery technology to external eLabeling experts.
Save Paper Costs
Eliminate the potential of having to manage and destroy large amounts of pre-printed IFUs. eLabeling ensures the correct information is always made available at minimum cost.
Simplify Processes
The ROBAR Destination Labeling module has the intelligence to understand which items have eIFUs associated with them and which ones need to be shipped with a paper IFU. It manages the printing of paper IFUs at the time of packaging and does this based upon location.
Use a Mechanism For Notifying Users Of eIFU Changes
Having an eIFU system in place allows for the opt-in capture of contact information for use in notifying website visitors of changes to eIFUs. This and other forms of support for regulatory requirements that must be followed by in vitro diagnostics (IVD) and/or medical device manufacturers is part of the value of having an eIFU management system for eLabeling.
We Work With Organizations Around the World
We provide complete systems, modular systems, consulting, training, and exemplary 24/7 support services across all borders and time zones.