Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak

On 9 April 2020 the UK MHRA published the guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home.

Due to the COVID-19 pandemic, remote working has increased. Some organisations have advised that their processes for approving paper documents with wet ink signatures are no longer achievable.

This guidance is to enable organisations to consider alternative methods whilst maintaining basic control of documents.

The guidance is for organisations involved in the pharmaceutical lifecycle (GMP, GDP, GLP, GCP & GPvP) or GLP studies regulated by the MHRA.

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