Articles from Validation Times (October 1, 2003)

Title	Author	Type	Words
"Critical" data key to determining risk-based Part 11 compliance plan: FDA.	Reid, Ken		622
Abbott using PAT to monitor batch records, raw materials.	Ludwig, Elisa		1141
Aventis cited for inadequate failure investigations, process deviations.			991
Blood bank letter shows FDA still concerned about computer system access, passwords under Part 11.			413
Challenge may be to R&D staff, not just QA/QC, says Mallinckrodt exec.	Ludwig, Elisa		733
Device reprocessor cited for failure to validate, clean, disinfect.			211
FDA not eyeing third party audits of raw materials; stressing C of As.	Sami, Tamra		1124
HDC cited for inadequate CAPAs related to design controls, bioburden testing.			354
Hospital bed manufacturer's electric beds not in conformance, repeat violations.			253
Industry, distributors, pharmacists disagree over level of GMPs, packaging to thwart counterfeiting.	Sami, Tamra		1304
Life-Tech cited for sterilization validation, other GMP issues.			402
Pfizer revalidates systems to become compliant following 70-item 483 for Pharmacia Sweden facility.			1156
Quintiles cited for validation, part 11 deficiencies.			832
Umbilical cord clamp manufacturer fails to implement corrective action.			656