Datacenters (DC): Qualification from a GxP point of view

Datacenters (DC): Qualification from a GxP point of view

Datacenter Qualification from GxP perspective In this entry we will introduce you in the DC GxP qualification. Initially we can encounter with one of the following scenarios: Scenario A: DC owned by the pharma company Scenario B: DC owned by the external supplier Scenario C: Sum of both previous scenarios (A and B) Scenario A:Read more about Datacenters (DC): Qualification from a GxP point of view[…]

Why is necessary to qualify IT Infrastructure and what does it mean?

Why is necessary to qualify IT Infrastructure and what does it mean?

IT Infrastructure Qualification One of the most important aspects to qualify the IT Infrastructure is the regulation compliance, in fact, it can be found in several points like: “The application should be validated; IT infrastructure should be qualified.” Eudralex, Volum 4, Annex 11. “GxP computerized systems should be validated for intended use, supporting infrastructure qualified,Read more about Why is necessary to qualify IT Infrastructure and what does it mean?[…]

“IT Infrastructure Control and Compliance” content

“IT Infrastructure Control and Compliance” content

ISPE GAMP® Good Practice Guide: IT infrastructure control and compliance guide: The first edition was published in 2005, the IT infrastructure used on these days is far from the current one. IT infrastructure has increased its power and it has appeared new systems that are vastly used by IT departments. In this second version theRead more about “IT Infrastructure Control and Compliance” content[…]

ISPE publishes new IT Infrastructure Control and Compliance

ISPE publishes new IT Infrastructure Control and Compliance

New guide IT Infrastructure Control and Compliance ISPE published new guide (Second edition). It is a guide where is detailed how to qualify IT infrastructure. Companies like Novartis, Novo Nordisk, Eli Lilly and other important ones have been contributed preparing this guide. FDA and MHRA are also regulatory contributors. Are you interested in understanding the guide?.Read more about ISPE publishes new IT Infrastructure Control and Compliance[…]