Articles from Validation Times (September 1, 2000)

Title	Author	Type	Words
'Audit logs' not acceptable under Part 11; audit trail more desirable: Hill.	Reid, Ken	Brief Article	440
200 inspectors train on Part 11, but focus still on submissions.	Fields, Howard	Brief Article	632
Anesthesia device maker cited for design controls.		Brief Article	629
Artificial skin maker's processes, water cited.		Brief Article	188
Canadian lenses detained for lack of design controls.		Brief Article	114
Contract sterilizer in U.K. hit on process validation.		Brief Article	106
Design changes snare 4 device firms; one cited for not doing risk analysis.		Brief Article	595
Design, process validation cited at Phoenix Medical.		Brief Article	165
Dow avoids 483 for bulk, but gets some notations.		Brief Article	874
EtO sterilization validation faulted at German firm.		Brief Article	239
FDA may ask firms to mail in process data after approval.	Reid, Ken	Brief Article	575
Fractionator feels sting of 'Team Biologics' auditing.		Brief Article	652
Merck contaminants hit; OOS averaging noted, too.		Brief Article	346
No consensus, but plenty of ideas at PQRI meeting.	Fields, Howard	Brief Article	762
Perrigo slapped for OOS, computers, dissolution.		Brief Article	332
Revalidation, microbe tests snare Geneva Labs.		Brief Article	582
Validation still not done in biologics; contaminants show up too often: Major.		Brief Article	478
Warning Letter Analysis.	McCarty, Mark	Brief Article	29
Water company slapped for process, design faults.		Brief Article	119