Articles from Validation Times (May 1, 2003)

Title	Author	Type	Words
Bugs in blood bank software not widely reported to users. (Blood & Biologics).			159
Cleaning validation missing evaluation of detergent residuals at Barr, change control, water system also need work. (Human drugs).			600
Development reports still a stumbling block in GMP Initiative. (CMC).	Sami, Tamra		935
Duramed challenged by impurities, discontinued product in re-inspection. (Human drugs).			740
Ethicon attributes holes in balloon to suppliers, customers, but gets 483. (Medical devices).			542
FDA to reward industry 'champions' implementing PAT with lower risk assignment. (Process analytical technology).	Sami, Tamra		756
Immunogenicity: how to regulate; how to test? (Analytical methods).	Sami, Tamra		1077
Inadequate cleaning and packaging validation raise concerns at Sharp. (Human drugs).			646
Legacy systems 'changed' no longer have 'legacy' status; final Part 11 guide forthcoming. (Electronic records).	Ludwig, Elisa		1933
No complaint handling adulterates surgical lights. (Medical Devices).			98
Pulmonetic ECOs were not validated, letter claims. (Medical Devices).			136
Software changes need validation in DMR, plasma association finds. (Blood & Biologics).			478
Systems validation, security needs not dead, though some firms think so. (Electronic records).	Ludwig, Elisa		657