Here at TradeTicity, we understand that serialization is a huge disruption. There are a lot of quality considerations to be made, and its your job to worry about them. For example:

  • Who will be in charge of implementing the project?
  • What are the quality implications of serialization?
  • Won’t there need to be extra checks?
  • What about reworks?
  • We don’t have this knowledge in-house!
  • Who will create the documentation?
  • How will I budget for this?
  • How can I be sure that the project will be successful?

Everything we do at TradeTicity is lead by quality. Our quality specialists were recruited from leading pharmaceutical manufacturers, so they worry about the same things you do. Our software was built according to GAMP5 principles, 21 CFR part 11 and EU Annex 11 for Computerized Systems. We have also integrated many hundreds of partners, we were one of the first companies to connect directly to the EU Hub, and have serialized billions of codes already.

Furthermore, the software is designed to be compliant-ready for any new upcoming legislation

Our defined processes will step you through the creation of your Project Plan, with predefined specifications and quality attributes. The implementation of serialization is an opportunity to build-in quality checks and automate some of the manual processes, so that we can help you to use serialization to improve your processes, reduce overall costs and reduce the risk of manual errors.

With automation, comes better standardization of practices, so that you produce a more consistent product.

We create electronic Master Records, which reduce the need for paper documents, and document control.

We can guide you through the entire serialization process – from L5 down to L1, for all of your lines, all of your sites AND all of your contract manufacture. Creating your Project Plan also makes sure that the budget is on target too.

If you have any questions on serialization, just contact us, we’re happy to help!