Labeling and Identification in Life Sciences – A Perfect Storm?

At least a couple of times today I heard the various regulations currently being drafted around the area of product labeling and identification as a ‘Perfect Storm’, driving Life Sciences companies to address these issues.

While Pedigree requirements have been deferred in the US, the US FDA continues to make progress with their UDI initiative that would require unique product identification for medical devices, at least to the level currently required for ethical drugs (requiring the National Drug Code, expiry date and batch number to be included in human and machine readable format) and blood products (where the international ISBT 128 standard is required).

At the same time, the European Union is slowly making progress on the issue of serialization, which is of course already a requirement in many countries for some classes of medical device.

While individual software solutions can help in these areas (see below), the implications of these requirements on Life Sciences companies may be enormous. While many Regulated Companies are seeing this as solely as an IT issue, the reality it is that in some cases complying with these regulations will require significant changes to supply chain models and significant investments in terms of upgrading facilities or even setting up complete new packaging, labeling and distribution centers.

While the business issues are enormous at least some of the software vendors are taking the issue seriously. Here at Oracle OpenWorld there are numerous vendors with labeling and printing solutions, but the most significant news from Oracle is the pending availability of their Oracle Pedigree and Serialization Manager (OPSM), which is set to be at the heart of many serialization and labeling solutions.

OPSM provides the ability to generate and manage serial numbers, interface to ERP and labeling/packaging systems and the ability to submit secure serial numbers to the proposed Government databases . Even better, OPSM is significantly ‘software service’ enabled which means that it is relatively easy to integrate with external systems (it is one of Oracle’s first ‘Fusion Applications’, having been developed on Oracle’s open standards based Fusion Middleware), with the majority of transactions running in the background (generating, tracking and submitting serial numbers, maintaining a database of packaging hierarchies etc).

The use of integrated Fusion Middleware based Business Intelligence means that users in the Life Sciences industry will be able to focus on exceptions (suspect serial numbers, potential counterfeited product, matching and authorizing returns etc) without having to manually interchange data between systems. While other serialization products exist, OPSM has the potential to be at the center of serialization business processes in pharmaceuticals and medical devices, uniquely integrating ERP systems, shop floor packaging and labeling systems and submission to the coming Government databases.

Based on the traffic at the OPSM stand in the OpenWorld exhibition hall there appears to be a good deal of interest in the product - there is certainly a need given current and pending regulations in this area. It will be interesting to see how many Regulated Companies really understand the nature of the coming “Perfect Storm” and translate their interest in OPSM in to real world solutions.