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Abstract:
Companies dealing with industry or government regulations are often required to meet specific standards for system security,
audit trails, and verification of electronic documents. With electronic data increasingly replacing printed documentation,
new strategies are needed for dealing with regulatory com (...)
Excerpt related to
fda regulatory compliance plm:
Introduction to Regulatory Compliance for Learning Management Systems. Source: GeoMetrix
Data Systems Inc. Document Type: White Paper ...
Published:
2010-03-11
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Abstract:
While the race for the pole position in the still evolving, moving-target PLM market started several years ago, it has been
quite accelerated by Agile Software's fourth acquisition in 2003. Particularly with the most recent Agile-Eigner announcement,
the two players have apparently decided to leapfrog ma (...)
Excerpt related to
fda regulatory compliance plm:
While the race for the pole position in the still evolving, moving-target PLM market started several years ago, it has been
quite accelerated by A...
Published:
2003-10-22
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Abstract:
The future of the PLM Suite will include more applications that cover product-related functionality and further expand the
benefits available. As the PLM Suite matures, companies will benefit from increased functionality and increased integration
between business processes. The ultimate expression of t (...)
Excerpt related to
fda regulatory compliance plm:
The Many Faces of PLM Part Two: The Future of the PLM Suite. Jim Brown - December 30, 2003.
Comments: 0. Read Comments The Future of the PLM Suite. ...
Published:
2003-12-30
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Abstract:
To gain the competitive edge, enterprises are seeking tools to break information silos. Collaborative planning and manufacturing
has given plant-level systems a whole new meaning. (...)
Excerpt related to
fda regulatory compliance plm:
To gain the competitive edge, enterprises are seeking tools to break information silos. Collaborative planning and manufacturing
has given plant-l...
Published:
2005-11-23
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Abstract:
Strategies for Overcoming Compliancy Issues in the Pharmaceutical Industry: a recipe for success. To successfully meet compliance
demands, pharmaceutical manufacturers must develop, implement, and track the effectiveness of a company-wide compliance strategy.
Key to that strategy is to adopt industry-spec (...)
Excerpt related to
fda regulatory compliance plm:
Strategies for Overcoming Compliancy Issues in the Pharmaceutical Industry: a recipe for success. To successfully meet compliance
demands, pharmace...
Published:
2010-03-11
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Abstract:
Top 10 PLM Pitfalls To Avoid. Get Free Knowledge and Other Software to Define Your Assessment According To 10 PLM Pitfalls
To Avoid. Product lifecycle management (PLM) implementation strategies are in many cases unique from company to company. However,
it is not uncommon for companies to encounter some of (...)
Excerpt related to
fda regulatory compliance plm:
Top 10 PLM Pitfalls To Avoid. Get Free Knowledge and Other Software to Define Your Assessment According To 10 PLM Pitfalls
To Avoid. Product lifecy...
Published:
2010-03-11
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Abstract:
After receiving US Food and Drug Administration (FDA) approval for its ground-breaking product, medical technology startup
Thermage, Inc., was looking to install manufacturing software that would fit a limited budget and meet its long-term needs.
By going with Expandable ERP, Thermage was able to impleme (...)
Excerpt related to
fda regulatory compliance plm:
... going with Expandable ERP, Thermage was able to implement a full-featured manufacturing system that helped
it ramp up production and maintain FDA compliance. ...
Published:
2010-03-11
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Abstract:
Although its PLM solutions will not likely be the "all things to all people" any time soon, Oracle might be showing us its
ability to develop its own applications in collaborative effort with its prominent customers. (...)
Excerpt related to
fda regulatory compliance plm:
... the first time seriously tackles regulatory compliance across several
... secure audit trails (for compliance with the Food and Drug Administration's [FDA]
21 CFR ...
Published:
2004-01-05
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Excerpt related to
fda regulatory compliance plm:
... alerts inside the system, immediately notifying Quality & Compliance to investigate
... to the US Food and Drug Administration’s (FDA) regulatory and validation
...
Published:
2010-06-15
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Abstract:
Enterprise application providers wanting to address the distinct regulatory requirements of the automotive, food, safety,
and life sciences industries need to offer enterprises industry-oriented enterprise resource planning systems that are sound
and compliance-ready. (...)
Excerpt related to
fda regulatory compliance plm:
Enterprise application providers wanting to address the distinct regulatory requirements of the automotive, food, safety,
and life sciences indust...
Published:
2007-03-02
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Abstract:
Combining process industry–oriented product lifecycle management capabilities with process manufacturing–oriented enterprise
resource planning ones can help alleviate many of the challenges particular to the process manufacturers, especially in the
areas of product development and regulatory complian (...)
Excerpt related to
fda regulatory compliance plm:
Combining process industry–oriented product lifecycle management capabilities with process manufacturing–oriented enterprise
resource planning one...
Published:
2009-03-16
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Abstract:
Combining process industry–oriented product lifecycle management capabilities with process manufacturing–oriented enterprise
resource planning ones can help alleviate many of the challenges particular to the process manufacturers, especially in the
areas of product development and regulatory complian (...)
Excerpt related to
fda regulatory compliance plm:
... Food and Drug Administration (FDA) regulations ... Implementing and
ensuring compliance with employee safety ... which are often delineated by regulatory
permits), and ...
Published:
2009-03-16
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Excerpt related to
fda regulatory compliance plm:
... whether it be for the FDA, ISO, or ... Because regulatory
compliance typically requires tracking/traceability and reporting of product related data, PLM
provides a ...
Published:
2011-04-18
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Excerpt related to
fda regulatory compliance plm:
... following capabilities: The US Food & Drug Administration (FDA) and other regulatory
compliance; Lot and serial number traceability; ...
Published:
2008-02-11
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Abstract:
The name Omnify Software may hardly come to mind when one thinks of the product lifecycle management (PLM) leaders, but that
might change down the track (...)
Excerpt related to
fda regulatory compliance plm:
The name Omnify Software may hardly come to mind when one thinks of the product lifecycle management (PLM) leaders, but that
might change down the...
Published:
2009-02-20
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Abstract:
Invensys must communicate its successes and strategy to the marketplace, and must aggressively invest in customer satisfaction,
marketing, and sales. IPS must convince customers and prospects that it is here to stay; while the functionally rich products
are great advantages, many other considerations mak (...)
Excerpt related to
fda regulatory compliance plm:
Invensys must communicate its successes and strategy to the marketplace, and must aggressively invest in customer satisfaction,
marketing, and sal...
Published:
2003-05-14
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Abstract:
ERP Issues for the Midsized Life Sciences Company. Find White Papers, Case Studies, and Other Resources Associated with the
ERP Issues for the Midsized Life Sciences Company What makes your enterprise resource planning (ERP) requirements difficult
for most vendors to satisfy? As a life sciences company, y (...)
Excerpt related to
fda regulatory compliance plm:
ERP Issues for the Midsized Life Sciences Company. Find White Papers, Case Studies, and Other Resources Associated with the
ERP Issues for the Mids...
Published:
2010-03-11
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Abstract:
Many food companies are investing significant funds in building awareness for their brands in the market, which can pay off
amply in competitive, commodity markets. One highly publicized recall, however, can turn an established brand asset into a
liability. (...)
Excerpt related to
fda regulatory compliance plm:
... With the FDA having authority over about 80 ... product lifecycle management
(PLM) must integrate ... best practices, customer requirements, and regulatory
compliance. ...
Published:
2006-11-02
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Abstract:
Adonix is fulfilling its promise to bring a full Process ERP offering to the mid-market. The new Adonix X3 Process automates
and integrates the complex formula management and planning requirements of process manufacturers, however, the vendor needs
to resolve knowledge and experience issues with the exis (...)
Excerpt related to
fda regulatory compliance plm:
Adonix is fulfilling its promise to bring a full Process ERP offering to the mid-market. The new Adonix X3 Process automates
and integrates the co...
Published:
2003-05-31
-
Excerpt related to
fda regulatory compliance plm:
... regulations, including the Food and Drug Administration’s (FDA’s) Title ...
the solution you’re using to reduce cycle times and manage regulatory compliance. ...
Published:
2008-07-21