Pharmaceutical Technology-11-01-2003

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

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.

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.

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

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