Sunday, 14 May 2017

Embracing the Cloud to Assure Data Integrity


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.”

The article can be accessed here: PM

Posted by Dr. Tim Sandle