Documentation
Article 7
1. The business operator shall establish and maintain appropriate documentation in paper or electronic format with respect to specifications, manufacturing formulae and processing which are relevant to compliance and safety of the finished material or article. 2. The business operator shall establish and maintain appropriate documentation in paper or electronic format with respect to records covering the various manufacturing operations performed which are relevant to compliance and safety of the finished material or article and with respect to the results of the quality control system. 3. The documentation shall be made available by the business operator to the competent authorities at their request.