Current Regulatory News

In March 2018 the MHRA released updated guidance on data integrity.  The guidance is now applicable across the GxP areas but does not apply to software in, or controlling, medical devices. The guidance is more closely harmonised with guidance issued by other authorities such as PIC/S and the WHO.  Read the new guidance here.

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The EU have announced an update to EU GMP Annex 11, expected during Q4 2018.

Nuncius Compliance Solutions News

Nichola will be attending the GAMP UK forum in Reading on 25th April 2018 - if you are there make sure to stop for a chat!

Week starting April 30th 2018 Nichola, along with Barry McManus of Empowerment Quality Engineering, will be delivering face to face CSV training in Malaysia on behalf of the RQA and WHO.

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Nichola will be presenting at the RQA Annual Conference in Manchester, 31st October to 2nd November - get more info here.