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Pharma customers benefit from GDP certificate

Schmitz Cargobull Telematics passes GDP audit by the TÜV

Explains what the feature is or what its benefits are to the user or customer.

 

 

2019-506 S.KO COOL

 

January 2019 – Pharma customers, who are required to demonstrate the safety of their processes in GDP audits every year now have a strong partner at their side in the transport sector. “We have passed the GDP audit for our TrailerConnect unit and the telematics service portal with flying colours,” reports Marco Reichwein, Managing Director of Schmitz Cargobull Telematics. TÜV SÜD tested the hardware and software and certified both as GDP-compliant at the end of 2018.

 

Schmitz Cargobull Telematics passes GDP audit by the TÜV

 

The pharmaceuticals industry has been growing rapidly worldwide for years. In Germany alone, sales in 2017 were €41.5 billion (an increase of five per cent over the previous year). The transport volume and particularly the demand for end-to-end monitoring and documentation of the supply chain are growing in parallel with this. So, as early as 2013, the European Commission introduced the “Good Distribution Practice of medicinal products for human use (GDP)” for quality assurance and protection against counterfeit medicines. Manufacturers, pharmaceutical wholesalers and pharmacists must have their processes GDP-audited annually. “With our GDP certificate we can ensure and document comprehensive process safety over the entire supply chain from the recording of the data in the trailer and its storage through to its presentation in the portal or its transmission in the API (interface for the transfer of data to third-party systems)”, explains Hendrik Voth, Product Manager at Schmitz Cargobull Telematics.

 

 

 

Certificate is valid for two years

As part of the auditing, the following subject areas were viewed in detail: interface description, data storage, data protection, risk analysis for software development / software updates / data protection, the software manual, sensor specification, company description, the management report for 2017 and the ISO 9001. “In contrast to many other companies, we now possess an official certificate with a test and accreditation number from TÜV SÜD”, explains Voth. This is valid for a period of two years.

 

 

 

“Our customers can, of course, request this certificate from us for their GDP audit,” says Reichwein. This saves them additional expense and allows them to demonstrate they are now fully compliant with regard to safety documentation for the entire supply chain.

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