THE Therapeutic Goods Administration (TGA) has posted on its website details around its expectations with relation to data management and data integrity as part of good manufacturing processes (GMP).
The TGA says it uses ALCOA principles (Attributable, Legible, Contemporaneous, Original, and Accurate) as well as ALCOA+ (which includes ALCOA plus Complete, Consistent, Enduring, and Available) that are required to ensure the integrity of data, irrespective of how it is generated.
New data released by Gemalto found that 1,792 data breaches led to almost 1.4 billion data records being compromised in 2016 as hackers targeted large-scale databases in industries across the world - breachlevelindex.com.
The healthcare industry was hardest hit, Gemalto reports, accounting for 27.5% of all breaches, and increased from 2015 numbers by 10.8%.
Visit tga.gov.au for more.
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