Archiving services in compliance with GLP

Webinar:Archivdienstleistungen in GLP-Konformität

On the 25th of May 2016 Iron Mountain Switzerland has been attested GLP compliant archiving services by the Swiss authorities

Zug – 17. June 2016. Through the course of countless inspections and audits, Iron Mountain, the worldwide leader in Records Management, shows that quality is no accident. As of recently Iron Mountain may manage those highly regulated GLP records in Switzerland, too.

What is GLP? Good Laboratory Practice is a quality system! Good Laboratory Practice regulates the formal quality standards for the enrollment of (non-clinical) studies, which target licensing of certain product groups. These are pharmaceuticals, cosmetics, pesticides, dietary supplements, etc.

Who manages GLP? Beginning in the eighties, the OECD, together with its members, compiled the GLP. In Switzerland, a country belonging to the OECD too, GLP is written into the law: the ordinance on Good Laboratory Practice (OGLP, SR 813.112.1). The Swiss GLP authorities are FOEN, FOPH and Swissmedic. GLP is law!

Why are GLP records so important for GLP? GLP aims at simplifying multinational approval procedures for enterprises and, in the end, to protect the public. Thanks to the standardized basic parameters in the execution of GLP studies, study results can easily be accepted in other member countries. To ensure this, it is imperative that after completion every record of a study is properly archived. Attention, this means: what is not documented and archived, cannot be part of the study!

What does GLP mean for Iron Mountain Switzerland? The Swiss authorities have attested on the 25th May 2016 that Iron Mountain Switzerland may offer GLP compliant archiving services. Working closely with the customers and the authorities under GLP compliance is a huge responsibility. As quality is a number one priority, it was only natural for Iron Mountain Switzerland to take this step. GLP records may now be archived with Iron Mountain Switzerland, too!

For everything concerning GLP at Iron Mountain Switzerland please refer to:

  • Dr. Robert Heimann
  • Business Development Manager & Head GLP
  • T: +41 58 810 22 88
  • robert.heimann@sispace.ch

Iron Mountain Switzerland can be found as Sispace AG on the official list of Swiss GLP enterprises:

www.bag.admin.ch

What does Iron Mountain do? The core business of Iron Mountain lies clearly in archiving records. This outsourcing service is common practice with enterprises working in highly regulated markets under high quality standards. No wonder that these enterprises engage Iron Mountain on a worldwide scale. Each country has its own standards and surveillance authorities. On one hand, Iron Mountain is always aware of local standards while also fluently speaking local languages. On the other hand, one finds in Iron Mountain the one Global Player with whom any Head of Records Management can converse at eye level about global strategy.

Global facts about Iron Mountain

  • More than 220.000 enterprises as customers
  • Archive infrastructure of more than 7.4 million square meters
  • More than 1‘350 facilities
  • 45 countries and counting...

More information on www.ironmountain.ch