Articles from Validation Times (June 1, 2006)

Title	Author	Type	Words
483 citations for environmental monitoring down; not even in top 30.	Reid, Ken		443
API manufacturer clears FDA inspection.	Pickett, Joseph		393
Diazyme Labs 19-item 483 notes equipment calibration and maintenance flaws.	Pickett, Joseph		444
Electronic records and software validation cited in 21-item Carolina Liquid 483.	Pickett, Joseph		532
Equipment contamination and poor quality audits highlight 18-item 483 to Bausch & Lomb; cleaning solution recalled.	Pickett, Joseph		814
Experts disagree on allowing handicapped personnel in firms' clean rooms.	Reid, Ken		423
Failure to investigate nonconformities trips up Smiths Group.			128
Failure to investigate OOS nets letter for Wyeth.			706
Firms seeking to validate spreadsheets should eye 2 internal FDA guides.			381
Inspectors to spend more time watching processes under new compliance program; parametric release CPG in offing, too.	Reid, Ken		585
Neil Labs written up for failure to establish appropriate specs.			484
Quality Aspirators didn't implement/record method changes.			534
Resonance Technology nets 7-item 483 for CAPAs, quality plans/procedures.	Pickett, Joseph		340
SAFE consortium seen clarifying digital signatures, new guide awaiting okay.	Dutton, Gail		901
Therics Spine comes up short in quality audits.			367
Tri-State fails to validate processes.			236
Westone Labs lacks effective QS, QA.			162