CONFIGURATION MANAGEMENT. Presentation to :. SOUTH AFRICAN PHARMACEUTICAL REGULATORY AFFAIRS ASSOCIATION Carol Cotty. Date : 21 November 2008. File Name : SAPRAA. SCOPE. Configuration Management Problem and Background Time Line Why Re-engineer CM? The Goal The How.
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SOUTH AFRICAN PHARMACEUTICAL REGULATORY AFFAIRS ASSOCIATION
Date: 21 November 2008
File Name: SAPRAA
Understood to be ...
Configuration Managementis not…
Documentation Management is …
1960’s early US Defence Force documents
1960s late First USA Military Standards 480 series
1970s mid CM Process re-engineered (CMII)
1992 MIL-STD-973 - Released
1994 MIL-STD-973 - Cancelled
1995 ISO 10007 - Updated 2003
1998 ANSI/EIA 649 - Updated 2004
WHAT IS OUR EXPERIENCE?
40% - 60% resources spent on intervention
ELIMINATES CORRECTIVE ACTION (CONT.)
Studies by the ICM and in SA indicate …
HOW DID WE DO ?
THE COAL OF CMII (CONT.)