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Abstract:
Compliance with regulatory requirements is a business-critical need you must maintain. But meeting this need is more challenging
with the creation of new regulations, such as 21 CFR Part 11, governing the use of software for secure data processing. But
compliance is possible: an enterprise resource plann (...)
Excerpt related to
cfr 21 11:
Managing Compliance with 21 CFR Part 11. Source ... needs.
Download <strong>Managing Compliance with 21 CFR Part 11</strong>.
Comments: ...
Published:
2010-03-11
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Abstract:
Compliance with US FDA regulations is a market requirement. Thus, among the nearly 1,500 installations of mySAP ERP software
among pharmaceutical, medical diagnostics and devices, and biotechnology companies worldwide, it is vital to be aware of the
functions and features of mySAP ERP that demonstrate te (...)
Excerpt related to
cfr 21 11:
Complying with US FDA Title 21 CFR Part 11 for the Life Sciences Industry.
Source: SAP. Document Type: White Paper Description: Compliance ...
Published:
2010-03-11
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Excerpt related to
cfr 21 11:
... What can help? A software solution that implements automated controls that address compliance issues,
including 21 CFR Part 11. ...
Published:
2008-07-21
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Abstract:
When it comes to US Sarbanes-Oxley Act (SOX) compliance, the role of financial information systems simply cannot be overlooked.
This was recently underscored by a study naming "financial systems and procedures" as the most common problem among companies
disclosing material weaknesses. Indeed, this weakne (...)
Excerpt related to
cfr 21 11:
Leverage Your Financial System to Enable Sarbanes-Oxley Compliance: An Evaluator’s Guide. Source: CDC Software. Document Type:
White ...
Published:
2010-03-11
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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
cfr 21 11:
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:
For a vendor, focus is good, as it often results with more value to its targeted customers. A highly focused vendor can
also remain profitable even in difficult economic times. One example of a vendor delivering more by covering less is Ross
Systems. (...)
Excerpt related to
cfr 21 11:
... To that end, Ross is adding functions to meet the new CFR 21 Part 11
(Code of Federal Regulations Title 21) for life sciences, and food & drug administration ...
Published:
2002-04-10
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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
cfr 21 11:
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:
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
cfr 21 11:
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:
While an increasing demand for services and incremental purchases of new extended-ERP functionality from existing client
base, with a modest ooze of new accounts and even a notable influx of new accounts for distinguished some, may not put the
revitalized former ERP losers back on top of the enterprise a (...)
Excerpt related to
cfr 21 11:
While an increasing demand for services and incremental purchases of new extended-ERP functionality from existing client base,
with a modest ooze ...
Published:
2003-03-20
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Abstract:
Ross Systems has come a long way as seen by TEC at the recent Rossworld user conference. The company’s progress is impressive,
but is Ross attempting to tackle too many requirements at once? (...)
Excerpt related to
cfr 21 11:
Ross Systems has come a long way as seen by TEC at the recent Rossworld user conference. The company’s progress is impressive,
but is Ross attemp...
Published:
2002-12-17
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Abstract:
For every vendor, focus often results with more value to its targeted customers. Two highly focused vendors that also remain
profitable and growing even in these difficult economic times, Ross Systems and Prescient Systems, are thus seemingly poised
to offer enriched combined value proposition to their (...)
Excerpt related to
cfr 21 11:
For every vendor, focus often results with more value to its targeted customers. Two highly focused vendors that also remain
profitable and growi...
Published:
2002-08-05
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Abstract:
Explore the five must have enterprise resource planning (ERP) features for medical device manufacturers.This whitepaper is
ideal for medical industry. In the medical device manufacturing industry, errors can cost more than money—they can cost lives.
In order to meet safety regulations, manufacturers are (...)
Excerpt related to
cfr 21 11:
... Management System are especially useful in meeting the complex regulatory requirements of medical device
manufacturing, including 21 CFR Part 11." Source: Plex ...
Published:
2010-03-30
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Abstract:
In the life sciences industry, marketing operations (in particular the packaging, labeling, and final steps of new product
development) remain virtually untouched by the computerized systems integration pervading the rest of the sector. However,
cost-effective approaches do exist for digital workflow and (...)
Excerpt related to
cfr 21 11:
A New Prescription for Improving Global Labeling and Packaging Operations. Source: Paxonix. Document Type: White Paper Description
...
Published:
2010-03-11
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Abstract:
IPS was hoping that the early product vision and venerable reputation that Marcam has in the process manufacturing market
for providing plant-centric ERP solutions might finally play well to capturing the marketing opportunity. (...)
Excerpt related to
cfr 21 11:
... regulatory requirements, enterprises with legacy ERP instances have been demanding that their vendors
extend their depth in areas such as 21 CFR 11 Part 11
...
Published:
2004-10-15
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Abstract:
IPS was hoping that the early product vision and venerable reputation that Marcam has in the process manufacturing market
for providing plant-centric ERP solutions might finally play well to capturing the marketing opportunity. (...)
Excerpt related to
cfr 21 11:
... regulatory requirements, enterprises with legacy ERP instances have been demanding that their vendors
extend their depth in areas such as 21 CFR 11 Part 11
...
Published:
2004-10-15
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Abstract:
Although its service-oriented architecture-based platform and enterprise solutions will not likely be "all things to all
people" any time soon, Oracle might be showing its ability to further develop its own enterprise infrastructure and applications
via a blitz acquisition of a Collaxa, a small and focus (...)
Excerpt related to
cfr 21 11:
Although its service-oriented architecture-based platform and enterprise solutions will not likely be "all things to
all people" any time soon, Or...
Published:
2005-03-14
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Abstract:
High-tech and electronics, chemical, and oil and gas industries each have their fair share of regulatory requirements to
meet, and an increasing number include environmental directives. Enterprise applications designed to meet their distinct needs
should help pave the way to compliance. (...)
Excerpt related to
cfr 21 11:
High-tech and electronics, chemical, and oil and gas industries each have their fair share of regulatory requirements to meet,
and an increasing n...
Published:
2009-03-20
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Abstract:
High-tech and electronics, chemical, and oil and gas industries each have their fair share of regulatory requirements to
meet, and an increasing number include environmental directives. Enterprise applications designed to meet their distinct needs
should help pave the way to compliance. (...)
Excerpt related to
cfr 21 11:
High-tech and electronics, chemical, and oil and gas industries each have their fair share of regulatory requirements to meet,
and an increasing n...
Published:
2009-03-20
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Abstract:
Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance. Find Free Device and Other Solutions
to Define Your Project In Relation To FDA Compliance and ERP/CRM Software. The US Food and Drug Administration (FDA) requires
pharmaceuticals and medical device companies to comply (...)
Excerpt related to
cfr 21 11:
Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance. Find Free Device and Other Solutions
to Define Your Projec...
Published:
2010-03-11
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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
cfr 21 11:
Invensys must communicate its successes and strategy to the marketplace, and must aggressively invest in customer satisfaction,
marketing, and sal...
Published:
2003-05-14