Quality Assurance

Index

A

Accessible record, 278

Adaptive design, 299

ADDIE, 109–112, 269

Adverse event, 9, 23–26, 51

Authorized record, 277–346

Awareness training, 197–201, 218, 220

B

Backed-up system, 276

Bioburden, 47–49, 59, 85, 91, 92, 98, 99

Business owner, 15, 16, 125, 157, 183, 206, 211, 321, 332

Business risk assessment, 169, 188, 220

C

Calibration, 10, 39, 40, 53, 54, 61, 66–76, 80, 101, 292

CAPA, (corrective acton/preventive action), 8, 13–15, 20–24, 29, 32–34, 37, 41, 45–50, 53, 54, 60, 64, 66–68, 73–76, 79, 81, 103, 124, 133, 153, 155, 169, 231, 239, 322, 326, 327, 334

Captured record, 276

cGMP, 31, 33, 101, 104, 144, 160, 167–173, 175–179, 181, 182, 184–189, 191, 192, 198, 199, 265, 324, 335

Change management, 53, 67, 74, 75, 330

Cleaning, ...