-
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
21 cfr part 11 software:
... 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 ...
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
21 cfr part 11 software:
... the nearly 1,500 installations of mySAP ERP software among pharmaceutical ...
ERP that demonstrate technical compliance with US FDA 21 CFR Part 11
Electronic Records ...
Published:
2010-03-11
-
Excerpt related to
21 cfr part 11 software:
... 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:
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
21 cfr part 11 software:
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:
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
21 cfr part 11 software:
... Plex Online provides a turnkey manufacturing ERP software solution for ...
requirements of medical device manufacturing, including 21 CFR Part 11."
Source: Plex ...
Published:
2010-03-30
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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
21 cfr part 11 software:
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:
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
21 cfr part 11 software:
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:
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
21 cfr part 11 software:
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:
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
21 cfr part 11 software:
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:
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
21 cfr part 11 software:
... and support of the Protean and PRISM process ERP software solutions and ...
to process manufacturing industries, by adding the 21 CFR Part 11
electronic signature ...
Published:
2004-10-15
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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
21 cfr part 11 software:
... is adding functions to meet the new CFR 21 Part 11
(Code of Federal Regulations Title 21) for life ... no changes to the base software,
including modifications ...
Published:
2002-04-10
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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
21 cfr part 11 software:
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:
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
21 cfr part 11 software:
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
-
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
21 cfr part 11 software:
... and support of the Protean and PRISM process ERP software solutions and ...
to process manufacturing industries, by adding the 21 CFR Part 11
electronic signature ...
Published:
2004-10-15
-
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
21 cfr part 11 software:
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:
The competition is becoming relentless given a slew of WMS vendors delivering sophisticated collaboration, visibility, and
SCEM functionality. Further many of them are also consistently profitable and have more visibility and mindshare. (...)
Excerpt related to
21 cfr part 11 software:
The competition is becoming relentless given a slew of WMS vendors delivering sophisticated collaboration, visibility, and
SCEM functionality. Fur...
Published:
2003-04-17
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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
21 cfr part 11 software:
... Source: CDC Software. Document Type: White Paper Description: When it comes to US Sarbanes-Oxley
Act (SOX) compliance, the role of financial information systems ...
Published:
2010-03-11
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Abstract:
Although Click Commerce is a thriving provider of on-demand supply chain management (SCM) solutions for a variety of worldwide
industries, it does have to face up to a variety of challenges, some of which are of its own making. (...)
Excerpt related to
21 cfr part 11 software:
Although Click Commerce is a thriving provider of on-demand supply chain management (SCM) solutions for a variety of worldwide
industries, it does...
Published:
2006-11-16
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Abstract:
Both HighJump's and OMI's customers should be pleased because these acquisitions should center their vendors’ supply chain
execution products inside a larger suite of complementary offerings and increase their vendors’ financial viability and market
visibility. (...)
Excerpt related to
21 cfr part 11 software:
Both HighJump's and OMI's customers should be pleased because these acquisitions should center their vendors’ supply
chain execution products ins...
Published:
2004-02-17
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Abstract:
It is becoming increasingly important for supply chain execution (SCE) suppliers to have global implementation and service
capabilities, while multinational user companies conversely benefit from working with global application providers. Now, the
two merged vendors, RedPrairie Corporation and LIS, shoul (...)
Excerpt related to
21 cfr part 11 software:
... with the Unite States FDA's (Food and Drug Administration) 21 CFR
Part 11 regulation. ... For example, a product acquired from Software
Architects a few years ago ...
Published:
2004-04-29