Innovatum Tackles FDA Labeling Requirements

Innovatum has taken the final wraps off a major update to ROBAR, a Windows program designed to help drug makers and medical device manufacturers design, manage, and print barcode and RFID labels. ROBAR version 2, which interfaces with ERP systems such as BPCS, can help companies comply with a barcode labeling requirement that went into affect last year, in addition to potential mandates some in the industry expect the Food and Drug Administration to make regarding RFID labels in the pharmaceutical supply chain.

ROBAR is designed to reduce the number of labeling errors by eliminating the manual input and manipulation of label information on packaging lines, particularly among large manufactures with multiple manufacturing sites. The software helps eliminate labeling errors by introducing standard downloadable label templates, by keeping an audit log of all changes made to labels, and by instituting a workflow process for new label approval.

In addition to improving the security of label printing, ROBAR helps manufacturers comply with requirements such as FDA’s 21 CFR Part 11, which mandated better tracking of changes made to computer systems used to manage the manufacturing of drugs, and the Prescription Drug Marketing Act, which went into affect last year and requires barcode labels to be used at the unit level.

It’s important to track the changes made to labels, because even a small change can have a big impact, according to Steve Brazzell, co-president of the Sugar Hill, Georgia, software company. “For example, the FDA may change the labeling, requirements for a particular drug to include an additional hazard statement,” Brazzell says. “Using the ROBAR Design Station, a label designer makes one change to the label data in ROBAR server’s database and every label template is automatically updated when used. In other systems, the designer may have to manually change hundreds of label files to accommodate even minor alterations. This can be costly and prone to error.”

Innovatum first started work on ROBAR in the early 1990s, when it developed a suite of AS/400-centric products for DuPont Pharmaceuticals. When Bristol-Myers Squibb purchased DuPont Pharmaceuticals, the company decided that ROBAR was exactly what it needed for managing labeling in all domestic manufacturing operations, says Ardi Batmanghelidj, Innovatum’s other co-president. “They asked us to significantly enhance the original version to be scalable at the enterprise level,” Batmanghelidj says. “In doing so we embarked on a complete re-write of the software, which continues to work well with the iSeries. However, because of its robust and generic XML interface engine, it will be used in SAP shops and will also connect with product lifecycle management systems such as Documentum.”

Various types of labels can be produced by ROBAR, including shipper labels, inner and outer labels, bulk and drum labels, patient chart labels, clinical trial labels, and manufacturing intermediate step labels. The software, which distributes copies of labels in the PDF format during the approval stage, supports more than 1,200 barcode printers from 45 manufacturers, the company says.

In addition to barcode labels, ROBAR can generate RFID labels. While the FDA has not yet made an RFID mandate, some industry organizations suspect that will change.

In particular, the Healthcare Distribution Management Association, a non-profit association of drug manufacturers and distributors, backs the expanded use of RFID technology in the nation’s drug supply chain. Last year, the HDMA recommended its members prepare to use RFID technology at the case level by December 2005, and at the individual unit level by 2007.

“Wide-scale [RFID] implementation appears to be a question of ‘when,’ not ‘if,'” the HDMA concludes in its December 2004 report, “EPC and Healthcare Distribution: Current State of the Industry. “HDMA and its member organizations have a clear choice: Take an active role in driving EPC developments in the industry, or risk being run over by them.” (You can download a PDF of that report by clicking here.

ROBAR is available now. Pricing starts at about $15,000. For more information on Innovatum and ROBAR, see www.innovatum.com.