Pharmaceutical Technology-11-01-2003

November 01, 2003

The authors describe how XML-based technology can be used to manage the creation of batch records.

November 01, 2003

FDA's revised guidance on 21 CFR Part 11 offers relief to the regulated industry by providing for enforcement discretion and suggesting a risk-based approach to compliance.

November 01, 2003

Although the main purpose of the proposed unit-of-use bar coding mandate is to reduce medication errors, manufacturers may find additional benefits to compliance, including reduced materials and finshed-good inventory requirements, improved sample management, and streamlined recalls.

November 01, 2003

Web services tehcnology allows manufacturers to integrate numerous independent applications and software.

November 01, 2003

Manufacturing exceptions and variability often can be managed more effectively through integrated, enterprise-wide systems.