Japanese–English glossary
Audit trail
監査証跡kansa shōseki
A secure, computer-generated record of who created, changed or deleted data, when, what the old and new values were and why. It underpins the reliability of electronic GMP records. Japan's expectations for computerized systems at manufacturers and marketing authorization holders are set out in the MHLW guideline on management of computerized systems (PFSB/CND Notification No. 1021-11, October 21, 2010). Japanese data integrity procedures add audit trail review (監査証跡レビュー): a person checks the audit trail for inappropriate changes or selective reporting of data, at a frequency set by risk. Having the function switched on is not enough; the review has to happen and be documented.