The documentation referred to in paragraph 1 must include two types of information to be kept for submission to the competent authority: ...
(b) records of the observations and/or measurements referred to in Article 3, results of the verification activities referred to in Article 4, reports and written accounts of decisions relating to corrective action when taken. An appropriate document management system must provide, in particular, for the easy retrieval of all documents relating to an identified production batch.
