Pharmaceutical Cloud Computing – safer than an on-site server?
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Pharmaceutical Cloud Computing – safer than an on-site server?

Pharmaceutical Cloud Computing As we evaluate pharmaceutical cloud computing as an option we see pharma companies are slow to adopt cloud computing services, mainly because of the perceived data security / data integrity risk and fear of regulatory interpretations.  I frequently hear, “How do you validate the cloud?” or “What will the regulator say?”, but most…

Ensuring Data Integrity Through ALCOA
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Ensuring Data Integrity Through ALCOA

The acronym ALCOA has been around since the 1990’s, is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice (GDP). ALCOA relates to data, whether paper or electronic, and is defined by US FDA guidance as Attributable, Legible, Contemporaneous, Original and Accurate. These simple principles should…

Data integrity – everything you wanted to know but too scared to ask

Data integrity – everything you wanted to know but too scared to ask

PharmOut is proud to offer you a new data integrity training course initially only to be offered in Melbourne and Sydney. Data integrity has been a significant concern for regulators for some time, we only need to look back at the world’s biggest medicines recall, see the TGA website for this Media Release from 24…

PDA suggest "Code of Conduct" for Data Integrity
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PDA suggest "Code of Conduct" for Data Integrity

Data Integrity The Parenteral Drug Association (PDA) recently released a free “Points to Consider” document to members that outlines a number of key elements that would make up a “Code of Conduct” for Data Integrity (DI) within the pharmaceutical Industry. The document was created as a result of collaboration of PDA members as part of…

Using cloud-based solutions in a regulated environment

Using cloud-based solutions in a regulated environment

Pharmaceutical manufacturers and other organisations operating under GMP-regulations have been hesitant to adopt cloud-based IT solutions. This is usually because they want to retain their data within their own four walls and because of the difficulty in maintaining the validated state of cloud-based software that can be updated without warning by the vendor. However, there…