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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
21 cfr part 11 compliance:
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
21 cfr part 11 compliance:
... it is vital to be aware of the functions and features of mySAP ERP that demonstrate technical compliance
with US FDA 21 CFR Part 11 Electronic Records ...
Published:
2010-03-11
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Excerpt related to
21 cfr part 11 compliance:
... 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:
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 compliance:
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:
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 compliance:
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:
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 compliance:
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:
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 compliance:
... had a new aim at delivering the US FDA compliance and control systems to process manufacturing
industries, by adding the 21 CFR Part 11 electronic signature
...
Published:
2004-10-15
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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 compliance:
... and more.Plex Online's integrated Quality Management System, Compliance Module,
and ... of medical device manufacturing, including 21 CFR Part
11." Source: Plex ...
Published:
2010-03-30
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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 compliance:
... had a new aim at delivering the US FDA compliance and control systems to process manufacturing
industries, by adding the 21 CFR Part 11 electronic signature
...
Published:
2004-10-15
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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 compliance:
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
21 cfr part 11 compliance:
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:
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 compliance:
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:
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 compliance:
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:
Governance, Risk, and Compliance for Life Sciences Companies: Institutionalize Compliance to Reduce Costs and Increase Productivity.
Find RFP Templates to Define Your Systems Implementation In Relation To Governance, Risk, and Compliance. Issues of governance,
risk, and compliance (GRC) affect nearly ever (...)
Excerpt related to
21 cfr part 11 compliance:
Governance, Risk, and Compliance for Life Sciences Companies: Institutionalize Compliance to Reduce Costs and Increase Productivity.
Find RFP Templ...
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
21 cfr part 11 compliance:
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:
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 compliance:
... as HACCP (Hazard Analysis & Critical Control Point) compliance, brand protection
... next iRenaissance release, 5.7, will provide full 21 CFR Part
11 support for ...
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 compliance:
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:
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
21 cfr part 11 compliance:
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:
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 compliance:
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:
HIPAA-Watch for Security is a tool designed to guide organizations through the risk analysis required by the Health Insurance
Portability and Accountability Act (HIPAA) compliance process (US). Relevant Technologies, a leading security research and
advisory firm, evaluated HIPAA-Watch for Security to ver (...)
Excerpt related to
21 cfr part 11 compliance:
... three years, and with the aftermath of 9/11, RiskWatch has ... Part
Two will cover Phase III and IV and will ... into law by President Clinton on August 21,
1996 and ...
Published:
2004-08-27