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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 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:
It’s old, it’s new, and it’s the future. Pedigree tracking regulations were originally passed into law through the Prescription
Drug Marketing Act of 1987 (PDMA). After two decades of postponing enforcement, the US Food and Drug Administration (FDA)
has lifted its final stay. Pharmaceutical compani (...)
Excerpt related to
21 cfr compliance:
Are You on Track for 21 CFR Part 203 Compliance? ... Download
<strong>Are You on Track for 21 CFR Part 203 Compliance?</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 compliance:
... companies worldwide, 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 ...
Published:
2010-03-11
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Excerpt related to
21 cfr 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 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:
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 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:
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 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:
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 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:
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 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:
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 compliance:
... and more.Plex Online's integrated Quality Management System, Compliance Module,
and ... requirements of medical device manufacturing, including 21 CFR
Part 11 ...
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 compliance:
... 4.1, which apparently had a new aim at delivering the US FDA compliance and control
systems to process manufacturing industries, by adding the 21 CFR 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
21 cfr compliance:
... 4.1, which apparently had a new aim at delivering the US FDA compliance and control
systems to process manufacturing industries, by adding the 21 CFR Part 11 ...
Published:
2004-10-15
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Abstract:
For today’s medical device manufacturer, today’s world is complex. The convergence of technology and implanted medical devices
has led to some of the most innovative and effective new medical therapies in history. Unfortunately, that convergence has
created tremendous complexities in the development, (...)
Excerpt related to
21 cfr compliance:
Patient Device Tracking: Integrating Customer, Physician, and Patient Data. Source: SAP. Document Type: White Paper Description:
For ...
Published:
2010-03-11
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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 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:
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
21 cfr compliance:
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:
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 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:
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 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:
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 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:
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 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:
About two-thirds of SoftBrands' revenue comes from its manufacturing division, which includes the Classic Fourth Shift solution
and Fourth Shift Edition for SAP Business One, the result of a joint initiative to integrate Fourth Shift functionality with
SAP Business One. (...)
Excerpt related to
21 cfr compliance:
About two-thirds of SoftBrands' revenue comes from its manufacturing division, which includes the Classic Fourth Shift
solution and Fourth Shift E...
Published:
2006-02-28