Annex 4 Guideline on data integrity 附录 4 数据可靠性指南 WHO | 2021-03 https://lib.shilinx.com:443/u/qobnrv
以WHO数据完整性指南为例，未明确规定由谁执行，由谁复核，可读性检查建议由数据备份人员执行，数据产生方复核。

Data backup, retention and restoration

11.15. Data should be retained (archived) in accordance with written policies and procedures, and in such a manner that they are protected, enduring, readily retrievable and remain readable throughout the records retention period. True copies of original records may be retained in place of the original record, where justified. Electronic data should be backed up according to written procedures.

11.16. Data and records, including backup data, should be kept under conditions which provide appropriate protection from deterioration. Access to such storage areas should be controlled and should be accessible only by authorized personnel.

11.17. Data retention periods should be defined in authorized procedures.

11.18. The decision for and manner in which data and records are destroyed, should be described in written procedures. Records for the destruction should be maintained.

11.19. Backup and restoration processes should be validated. The backup should be done routinely and periodically be restored and verified for completeness and accuracy of data and metadata. Where any discrepancies are identified, they should be investigated and appropriate action taken.

系统数据可读性可以定期抽样进行检查，法规没有明确哪个部门执行\复核，可以根据自己公司的情况，合理安排；建议质量部门审核。