+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. Overview

,

1.1 References

1.2 Identified Requirements

1.3 Related Standards

2. Identified Requirements

Requirements

3. Related Standards

Standards