Articles from Validation Times (November 1, 2001)

Title	Author	Type	Words
'MQs' touted for handling some legacy computers.	Lawrence, Terry	Brief Article	497
53% say validation doesn't improve instruments, only fits regulatory need, according to informal survey.	Whipple, Dan	Brief Article	616
AAPS to present FDA with paper on ligand-binding assays.	Whipple, Dan	Brief Article	478
Access is leading fault of legacy computers; other older equipment bugs FDA, too.	Lawrence, Terry	Brief Article	629
Aventis' Centeon gets 114-page EIR for validation lapses while on consent decree.		Brief Article	881
Braun's I.V. sets slapped for validation faults.		Brief Article	265
Chinese API maker looks to state for calibration service.		Brief Article	316
Compounding pharmacy hit for stability, sterility.		Brief Article	272
Dentsply stumbles on software validation in syringe devices.		Brief Article	223
Electrode maker fails to verify correction for 'dull needles'.		Brief Article	174
FDA hits CA firm with eight design citations.		Brief Article	207
FDA hits repackaging plant with standard GMP citations.		Brief Article	176
FDA homes in on record-keeping retention systems in Part 11 enforcement.		Brief Article	920
French firm hit for software, process validation, Part 11.		Brief Article	337
Irradiator subject of validation hits at two IL hospital blood banks.		Brief Article	342
OOS averaging nets OTC maker warning.		Brief Article	285
Part 11, MDR issues afflict maker of resuscitators.		Brief Article	286
Part-time processor bails out rather than face FDA validation rules.		Brief Article	557
Pharmacia drops supplier after Micronase recall.		Brief Article	314
Repackager needs quality control unit.		Brief Article	153
Swiss firm skips 483 despite retrospective validation.		Brief Article	511
Tablet press speeds, environmental controls trip small drug maker.		Brief Article	267
Tampa firm slapped for GMP, NDA deviations.		Brief Article	246
X-ray maker cited for design controls, environmental issues, calibration.		Brief Article	488