EMA GMP Q&A: IT and DI and its 1 linked instrument

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	EMA GMP Q&A: IT and DI	Annex 11 (2011)
Authority	EMA	European Commission
Legal weight	Guidance & Q&A	GMP guide & annexes
Status	Final	In force
Last verified	Not yet	Not yet
Summary	EMA questions and answers on applying EU GMP. The Annex 11 section covers spreadsheets, database security, validation and storage of electronic data. The data integrity section covers data risk, the data lifecycle, audit trails, review of electronic data, ALCOA and supply chains.	The current EU GMP annex for computerised systems used in GMP-regulated activities. It covers risk management, validation, data, audit trails, security, electronic signatures, periodic evaluation and business continuity. It stays in force until the revised Annex 11 is published and comes into operation.
Lifecycle	~1 Feb 2011 Annex 11 questions dated February 2011	~1 Jan 2011 Revision 1 published in EudraLex Volume 4 (January 2011) 30 Jun 2011 Came into operation
Source	Official text Source: EMA.	Official text Source: European Commission. Licensed under CC BY 4.0.

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