2019 - Information – Governance, Risk, Compliance

In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down.
Documentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product.
In order to maintain documentation in GxP/GMP compliant manner, information governance procedures should be developed and implemented. In the regulated industries, manufactures are required to use a change control procedure.
It is imperative to secure data, prepare for e-discovery, and be ready if crisis strikes.