ABSTRACT
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 507 Vendor Auditing Using GAMP4 Guidance and Templates . . . . . . . . . . . . . . . . 508
A Company Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 509 B Organization and Quality Management . . . . . . . . . . . . . . . . . . . 510 C Planning and Product, Project Management. . . . . . . . . . . . . . . . 512 D Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 512 E Implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 513 F Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 514 G Completion and Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 516 H Support and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 517 I Supporting Procedures and Activities . . . . . . . . . . . . . . . . . . . . 519
Training in GAMP 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 520 Who Are You Talking To? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 522 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 523
INTRODUCTION
The following case studies have been written from an information management department perspective. Most articles and presentations on practical applications of GAMP 4 seem to either cover computerized systems within the manufacturing or the laboratory area, either from the perspective of the user, the vendor, or the validation consultant. It is rare to come across the information technology (IT) or information systems (IS) perspective. Information management (IM), which encompasses IT and IS, plays a dual role, as the user and as the provider.
