Articles from Validation Times (December 1, 2003)

Title	Author	Type	Words
'Reason codes,' annotations advised to help with Part 11 compliance.	Ludwig, Elisa		999
Agency says repackager failed to provide evidence or documentation of corrective actions following audit.			228
Alternative therapy school's colonic irrigation systems lack 510(k).			224
American Mammographics lacks SOPs.			137
American Medical Devices lacks MDR, QC procedures.			331
Bourget cited for not doing infectious-disease testing of tissue donor specimens.			398
Configuration management more critical now, particularly for software; oversight board suggested.			720
FDA objects to company's revised Process Validation Protocol.			393
Korean device firm cited for failing to validate sterilization, plus MDR issues.			477
Ligand lacks refiltration, shipping validation.			787
Merck API plant nets 483 for lab control, data access issues under Part 11.			706
Overly detailed SOPs and too many changes are red flags for FDA.	Ludwig, Elisa		1025
Pfizer central stability lab nets 5-item 483 for quality, lab controls.	Sami, Tamra		1016
Software testing should reveal errors--not avoid them.	Ludwig, Elisa		737
Some validation consultants say lax FDA enforcement part of poor performance by industry.	Ludwig, Eliza		912