This module is designed to review some aspects related to creation, implementation, archiving, storage and destruction of documents in GxP environments. It goes onto discuss common failures in good documentation and steps to ensure integrity of data generated
|Who is it for||
This course is designed as basic training for all personnel involved in pharmaceutical manufacturing, quality, and engineering. It’s also relevant to employees in supply chain, accounts, finance and IT
|Why it matters||
The accurate capture of information plays an important role in the manufacture of pharmaceuticals and medical devices. Documentation is key to GMP compliance as it ensures traceability of all development, manufacturing, and testing activities. It also provides the route for auditors to assess the overall quality of operations within a company and its final product.