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12.
21 CFR Part 11 Electronic Records; Electronic Signatures
11.
Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application
10.
Inspection Guides: Computerized Systems in Drug Establishments (2/83)
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