COMPUTER-SYSTEM IMPLEMENTATION, BATCH STANDARDS AND VALIDATION

Today's market requirements drive companies in all industries to find ways to become more competitive, reduce project time lines and keep co sts low. We at Genzyme Corporation's new Allston Landing Biopharmaceut ical Manufacturing Facility have used standards - such as Instrument S ociety of America (ISA) draft standards for Batch Control Systems Mode ls and Technology (ISA dSP88.01) - to save engineering time, money and help us meet our Food and Drug Administration (FDA) regulatory object ives with respect to implementation of a process management system.