SAP Track & Trace
SAP’s Serialization and Track & Trace Solution Portfolio.Read more
For pharmaceutical organizations, understanding regulation and standards is critical to their success. GxP quality standards govern almost every aspect of drug development, from research to distribution.
As Track & Trace regulation spreads and evolves, understanding how regulation applies to each market is crucial. Failure to comply can mean a company cannot sell its goods in the market.
The introduction of serialisation requirements for the USA (via the DSCSA) came into force in November 2017, but the FDA deferred enforcement until November 2018 to allow companies more time to introduce the necessary serialisation measures. That deferment is now over and from November of this year (2018), serialisation is mandatory in the USA.
2019 is set to be a major year in the development of Track and Trace Regulation and will affect every pharmaceutical organization.
In addition to the above, several countries have announced the introduction of serialisation regulations including:
Knowing the regulation and understanding its use is mandatory for any pharmaceutical organization. This is not a “one-off” exercise and regulation is not static. Within the Track & Trace world, we have seen major changes to the various regulatory regimes. Keeping on top of the regulatory requirements is an ongoing necessity.
How Movilitas can help
Movilitas have more experience in the pharmaceutical Track & Trace world than any other solution supplier. We can provide services based on years of experience and will work with you to ensure that your organization understands and can fulfill its regulatory obligations.
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