https://us.v-cdn.net/6037949/uploads/BQWOIYO2QI5T/dist-718440-statement-of-compliance-to-japanese-eres-guideline-28v-01-29.pdf
https://us.v-cdn.net/6037949/uploads/U5RK90PEPVO1/21-cfr-part-11-assessment-v10.pdf
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