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FDA (미국 식품 의약국)

12.

21 CFR Part 11 Electronic Records; Electronic Signatures

11.

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

9.

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

8.

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

7.

Data Integrity and Compliance With CGMP Guidance for Industry

6.

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

5.

CPG Sec. 425.200 Computerized Drug Processing; Vendor Responsibility

4.

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

3.

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

2.

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

1.

CPG Sec. 460.400 Computerized Prescription Recordkeeping by Pharmacies

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