The Problem:
Implementing an enterprise-level, validated bar code labeling system with a clear path for future RFID implementation remains a significant challenge in the Life Sciences industry. Pharmaceutical and medical device manufacturers increasingly face the dilemma of maximizing supply chain operations while utilizing multiple Auto ID technologies (i.e. bar codes and RFID), and meeting regulatory compliance requirements. At a time when many still struggle with long-proven technologies like bar coding, recommendations from the FDA now have them scrambling to implement comprehensive RFID systems.
While RFID undoubtedly has exciting potential to protect the supply chain from counterfeit and diverted drugs, in reality, there are still significant obstacles to this scale of implementation (i.e. tag cost, read rates, data standards, etc.). This is not to say that manufacturers should ignore RFID. Instead, the goal should be to implement a single enterprise-class label system that handles todays requirements like bar coding and slap-&-ship RFID tagging, but also provides scalability to address more complex RFID applications like
epedigree and chain of custody when they become feasible.
The Solution:
There are a number of essential factors to consider in choosing an enterprise label solution for bar coding and RFID requirements in FDA-regulated industries:
Bar Code and RFID Support: Most industry analysts agree that RFID will not replace bar codes for many years - if ever. More likely, RFID will be utilized in conjunction with bar codes since failsafe options are essential in the event of damaged or corrupted tags. Therefore, it is important to choose a solution that allows both bar code and RFID data that meet the specifications of standards bodies like the UCC/EAN and EPC Global.
Integration: Manufacturers should be careful to choose a system that maximizes existing investments in ERP, PLM and similar enterprise applications. Thus, an ideal system must offer flexible integration options via standard interfaces like XML that can address a wide variety of platforms and applications.
Regulatory Compliance: While there are a number of applications for bar coding and RFID, very few meet the industry-specific challenges of
pharmaceutical and medical packaging device manufacturers. Therefore, the solution should incorporate explicit functionality to address regulatory compliance standards like 21 CFR Part 11. In addition, the vendor should have an excellent track record of implementing and validating solutions for
fda labeling requirements.
Central management and Scalability: The ultimate goal is to efficiently meet todays needs while effectively planning for tomorrows opportunities. Thus, the ideal system should allow for central management of label data and processes among any number of sites, and should also be scalable in terms of both licensing and functionality. Thus, it is crucial to ask potential vendors how their systems can flexibly address the changing needs of both the industry and the individual business.
