A Competitive Approach to Regulatory Compliance in Life ... - Apriso
A Competitive Approach to Regulatory Compliance in Life ... - Apriso
A Competitive Approach to Regulatory Compliance in Life ... - Apriso
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� Global Production Manager – Tracks and traces materials and products across the<br />
manufacturer’s enterprise and those of suppliers and contract manufacturers;<br />
� Global Performance Manager – Built on a robust KPI analytics eng<strong>in</strong>e, provides<br />
detailed visibility <strong>in</strong><strong>to</strong> production status, product attributes, SPC and quality for<br />
resources, material, labor and mach<strong>in</strong>es, both locally and across multiple locations.<br />
<strong>Life</strong> sciences manufacturers can now:<br />
� Easily vary processes <strong>to</strong> meet the regula<strong>to</strong>ry requirements of different regions<br />
� Support diverse manufactur<strong>in</strong>g methodologies, geographies, cultures and markets<br />
� Handle chang<strong>in</strong>g product l<strong>in</strong>es, processes and standards<br />
� More efficiently operate bus<strong>in</strong>ess systems by fill<strong>in</strong>g the “white spaces” where ERP<br />
systems have not been able <strong>to</strong> reach<br />
� Track, trace, manage and control best-practice processes across multiple-sites<br />
A Comprehensive Solution for<br />
<strong>Life</strong> Sciences Manufacturers<br />
The <strong>Apriso</strong> Global Manufactur<strong>in</strong>g Suite provides life sciences manufacturers, for the first time,<br />
with a <strong>to</strong>tal view of, and control over, their diverse manufactur<strong>in</strong>g operations, <strong>in</strong>clud<strong>in</strong>g<br />
warehous<strong>in</strong>g, time and labor, quality management and asset ma<strong>in</strong>tenance.<br />
It enables implementation of ARC Advisory Group’s Collaborative Production Management<br />
(CPM) model and ISA S95 model - each of which extends beyond traditional MES. More than<br />
just a production system, <strong>Apriso</strong>'s Global Manufactur<strong>in</strong>g Suite encompasses supply cha<strong>in</strong><br />
execution and collaborative manufactur<strong>in</strong>g – from receiv<strong>in</strong>g dock, suppliers and contract<br />
manufacturers on one side, <strong>to</strong> shipp<strong>in</strong>g dock and cus<strong>to</strong>mers on the other side.<br />
The <strong>Apriso</strong> solution enables paperless DHR and BR enforcement of processes across<br />
operations, as well as full report<strong>in</strong>g of actual execution results back <strong>to</strong> ERP systems of record.<br />
It provides management visibility and control over all the sub-systems shown <strong>in</strong> Figure 1 (with<br />
the exception of Design Controls, which are properly managed through a PLM system).<br />
6 A <strong>Competitive</strong> <strong>Approach</strong> <strong>to</strong> Regula<strong>to</strong>ry <strong>Compliance</strong> <strong>in</strong> <strong>Life</strong> Sciences Manufactur<strong>in</strong>g<br />
The <strong>Apriso</strong> Global<br />
Manufactur<strong>in</strong>g Suite<br />
provides <strong>Life</strong> Sciences<br />
manufacturers, for the<br />
first time, with a <strong>to</strong>tal<br />
view of, and control<br />
over, their diverse<br />
manufactur<strong>in</strong>g<br />
operations, <strong>in</strong>clud<strong>in</strong>g<br />
warehous<strong>in</strong>g, time and<br />
labor, quality<br />
management and<br />
ma<strong>in</strong>tenance.