Data
integrity issues in the manufacturing of finished pharmaceuticals and active
pharmaceutical ingredients (APIs) continue to be in the spotlight. Life
sciences companies are under increased scrutiny by regulatory bodies, as the
MHRA, FDA, EMA and WHO have all recently issued guidance on best practices for
end-to-end management of data records throughout the drug development
lifecycle.
Mike
Jovanis has written an interesting article on this subject for Pharmaceutical
Manufacturing. Here is an extract: “Modernize
with the cloud: Cloud applications tailored for life sciences quality processes
can extend data integrity across every part of the supply chain by capturing
every data-driven event. Easily configured to work with existing business
processes, the cloud ensures anyone who touches data - whether it’s uploaded,
reviewed or accepted - is automatically documented.”
Posted by Dr. Tim Sandle
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