FDA 
Food and Drug Administration / 미국식품의약국

21 CFR Part 11 Electronic Records;

Electronic Signatures

Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application

Inspection Guides: Computerized Systems in Drug Establishments (2/83)

Inspection Guides: Glossary of Computer System Software Development Terminology (8/95)

Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry

Data Integrity and Compliance With CGMP Guidance for Industry

CPG Sec. 425.100 Computerized Drug Processing; CGMP Applicability to Hardware and Software*

CPG Sec. 425.200 Computerized Drug Processing; Vendor Responsibility

CPG Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs

CPG Sec. 425.400 Computerized Drug Processing; Input/Output Checking

CPG Sec. 425.500 Computerized Drug Processing; Identification of "Persons" on Batch Production and Control Records

CPG Sec. 460.400 Computerized Prescription Recordkeeping by Pharmacies