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AMC1 ADR.OR.F.080 Record keeping

ED Decision 2020/021/R

DOCUMENTATION TO BE RETAINED

(a) The record-keeping system used by the organisation responsible for the provision of AMS should provide for adequate procedures, storage facilities, as well as the reliable traceability, retrievability and accessibility of the records related to its activities that are subject to Regulation (EU) 2018/1139 and its delegated and implementing acts throughout the required retention period.

(b) The records should be kept in paper or electronic format, or a combination of both. It is also acceptable to keep records stored in microfilms or optical discs. The records should remain legible throughout the required retention period. The retention period starts when the record is created or last amended.

(c) For paper-based systems, robust material should be used which can withstand normal handling and filing.

(d) Electronic systems should have at least one backup system which should be updated every 24 hours or each time a new entry is made. Electronic systems should include safeguards against the possibility for unauthorised personnel to alter the data.

(e) All computer hardware used to ensure data backup should be stored in a location different from that containing the working data, and in an environment that ensures they remain in good condition. When hardware or software changes take place, special care should be taken that all necessary data continues to be accessible, at least throughout the retention period. In the absence of any indication of the retention period, all records should be kept for a minimum period of 5 years.