21 C.F.R. § 1311.60   Recordkeeping.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 1311—Digital Certificates
Subpart B—Obtaining and Using Digital Certificates for Electronic Orders

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§ 1311.60   Recordkeeping.

(a) A supplier and purchaser must maintain records of CSOS electronic orders and any linked records for two years. Records may be maintained electronically. Records regarding controlled substances that are maintained electronically must be readily retrievable from all other records.

(b) Electronic records must be easily readable or easily rendered into a format that a person can read. They must be made available to the Administration upon request.

(c) CSOS certificate holders must maintain a copy of the subscriber agreement that the Certification Authority provides for the life of the certificate.

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