With the ever-evolving advancements of computerised systems and their involvements in the pharmaceutical, medical device, biotechnology and clinical trial industries, it is more critical than ever to ensure that these systems are appropriately assessed, validated and controlled. This is essential to safeguard the ensuing data integrity, product...
You’re a Quality, IT, or Operational manager working for a Pharmaceutical / Medical Device company, responsible for the computer systems used in-house. Working in the Pharmaceutical / Medical Device industry, means that regulators such as the FDA and TGA will scrutinise the use and validation of these business critical systems.
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