Falsified Medicine Directive - How do L4L5 solution vendors help with compliance?

Falsified Medicine Directive 4 of 5 – How can L4L5 solution vendors help customers get ready for compliance?

How can L4L5 solution vendors help customers get ready for the Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act (DSCSA)?

L4L5 solution vendors have to be quick and have the ability to make services available for early rollout. Too many times, in this industry we have made engineering tools fantastic, but they are difficult to implement. Tools need to be at the consumer level, simple. The tools have to be intuitive, simple and quick to implement. Easy to validation is key. The Pharmaceutical industry is validation heavy. If a solution vendors system can’t validate, then things can go wrong and disrupt ones supply chain. L4L5 solution vendors need to make it as easy as possible and ideally give an added value. It is such a new concept.

 

If a European Pharmaceutical Manufacturer buys a L4L5 solution vendor for Europe, does that mean they need to purchase other L4L5 solution vendors to fulfil other global compliance regulations?

Many solution vendors are only compliant for very limited geographical areas. Experience solution vendors know what they are doing, have experience with different modules and geographies. And as a pharmaceutical company expands, solution vendors can adapt. L4L5 solution vendors should provide an upgrade to fit customer needs at any point. It is important to pick a solution vendors that can fit your compliance needs now and in the future. An experienced L4L5 solution vendors will consider customers goals for the future. It is important that companies in the supply chain pick L4L5 solution vendors that will help reach those goals from the beginning.

 

About Glenn Abood: Abood is the CEO and founder of rfxcel. He has been providing track and trace solutions for the Pharmaceutical industry in US, Europe, India, Brazil for over 13 years. Glenn focuses on building a company with industry leaders and experts including, Mark Davison.

About Mark Davison: Davison is a serialization and track and trace expert in the European market with over 15 years’ experience bringing solutions to the Pharmaceutical industry.