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+Article 12 8. |
Article 12 8.The compliance part of the database shall be established in accordance with the following criteria:
(a)
protection from unintended use and the safeguarding of confidential information by way of strict security arrangements;
(b)
access rights based on the need-to-know principle;
(c)
processing of personal data in accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, as applicable;
(d)
limitation of data access in scope to prevent copying larger data sets;
(e)
traceability of data access for the supplier with regard to its technical documentation. 1. Prehľad
1.1 Odkazy1.2 Identifikované požiadavky1.3 Súvisiace štandardy2. Identifikované požiadavky
3. Súvisiace štandardy
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