Managing the Documentation Maze: Answers to Questions You Didn't Even Know to Ask

Index

Absence of records, in electronic record closed-system controls, 290

Abstracts, as documentation, 41

Acceptance, 287

implementing 21 CFR Part 11 and, 280

Access

in 21 CFR Part 11, 446

in 45 CFR § 164.308, 422

in 45 CFR Part 164 Subpart C, 418

Access control

in 45 CFR § 164.310, 424

in 45 CFR § 164.312, 424

in 63 FR 43242 (§ 164.312), 379–380

in 63 FR 43242 (§ 164.312), 374–375

Access establishment, in 45 CFR § 164.308, 422

Access modification, in 45 CFR § 164.308, 422

Accountability

in electronic record closed-system controls, 300

in 45 CFR § 164.310, 424

in 63 FR 43242 (§ 164.312), 375

Accountability impact, in 63 FR 43242 (§ 164.310), 373

Acronyms, 210

Active pharmaceutical ingredients, good manufacturing practice guide for, 45

Active voice, 208

Activities, documentation of, 38

Administrative assistants, for document management, 34

Administrative requirements, in 45 CFR Part 162, 414

Administrative safeguards

in 45 CFR § 164.308, 421–423, 428

in 45 CFR Part 164 Subpart C, 418–419

in 63 FR 43242 (§ 164.308), 356–370, 400–401

in 63 FR 43242 (§ 164.310), 371

Administrative Simplification rules

45 CFR Parts 160, 162, and 164 and, 405, 406

63 FR 43242 and, 389–390

Administrators, in electronic signature components and controls, 312

Advance notice of proposed rulemaking (ANPRM)

for electronic record closed-system controls, 288, 294

for 21 CFR Part 11, 262–263, 273, 274, 277 ...