# Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (Text with EEA relevance), Division 5

Extent: E+W+S+N.I.

When computerised systems are used, software, hardware and back-up procedures must be checked regularly to ensure reliability, be validated before use, and be maintained in a validated state. Hardware and software shall be protected against unauthorised use or unauthorised changes. The back-up procedure shall prevent loss of or damage to data at expected and unexpected down times or function failures.

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Source: https://www.legislation.gov.uk/eudr/2005/62/annex/division/4/division/5 (the official version)
Page: https://openlegislation.uk/eu-directive-2005-62/annex/division-4/division-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.