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Abstract:
For industries in regulated environments, validation of processes and systems is a required part of business. The goal of
the validation process is to provide confidence in a process or system by demonstrating consistent and repeatable results
through documented evidence. This article provides an overvie (...)
Excerpt related to
fda validation compliance:
... This article provides an overview of a validation for a computer software system, for
compliance with US Food and Drug Administration (FDA) regulations. ...
Published:
2010-05-07
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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
fda validation 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:
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
fda validation compliance:
... But compliance is possible: an enterprise resource planning (ERP) system can help with
audits, document and digital signatures, validation scripts, and other ...
Published:
2010-03-11
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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
fda validation compliance:
... HACCP (Hazard Analysis & Critical Control Point) compliance, brand protection ...
Life sciences customers using iRenaissance have achieved FDA validation and Ross ...
Published:
2002-04-10
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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
fda validation compliance:
... the process sector requiring regulatory compliance, deep production ...
assist regulated industries with validation needs ... Food and Drug Administration (FDA)
and the ...
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
fda validation compliance:
... the process sector requiring regulatory compliance, deep production ...
assist regulated industries with validation needs ... Food and Drug Administration (FDA)
and the ...
Published:
2004-10-15
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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 validation 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:
A broader, more structured approach is needed to effectively manage governance, risk management, and compliance (GRC). Enterprises
will then be better able to guide their people, standardize their processes, and unify technology to embed GRC at all organizational
levels. (...)
Excerpt related to
fda validation compliance:
A broader, more structured approach is needed to effectively manage governance, risk management, and compliance (GRC). Enterprises
will then be be...
Published:
2007-03-09
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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 validation 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
-
Excerpt related to
fda validation compliance:
... the system, immediately notifying Quality & Compliance to investigate ...
US Food and Drug Administration’s (FDA) regulatory and validation requirements ...
Published:
2010-06-15
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Abstract:
SAP's governance, risk management, and compliance roadmap is still in its beginning stages. Only time will prove the vendor's
delivery of true, tangible products (and not vaporware), as well as the success of those products with current and prospective
customers. (...)
Excerpt related to
fda validation compliance:
SAP's governance, risk management, and compliance roadmap is still in its beginning stages. Only time will prove the vendor's
delivery of true, ta...
Published:
2007-05-04
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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 validation 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:
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
fda validation 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
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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 validation 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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Excerpt related to
fda validation compliance:
... the Food and Drug Administration’s (FDA’s) Title 21 ... so it provides
you with the validation you need ... controls must be in place to ensure process compliance.
...
Published:
2008-07-21
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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
fda validation compliance:
... 483 letter from the FDA can cause ... the system must enable compliance
with additional ISO ... requirements for inspection, traceability, documentation, and validation.
Published:
2010-03-30
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Abstract:
Your Challenge: Get Decision Makers' Approval for HACCP Foundation Crumble. Specific, Measurable, Achievable, Relevant and
Time-Bound. Complying with current good manufacturing processes (GMPs) is no easy task for food manufacturers. Companies that
don t have a solid foundation to help with quality contro (...)
Excerpt related to
fda validation compliance:
Your Challenge: Get Decision Makers' Approval for HACCP Foundation Crumble. Specific, Measurable, Achievable, Relevant
and Time-Bound. Complying wi...
Published:
2010-03-11
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Abstract:
Today's enterprise is no longer a single, vertically integrated organization. Globalization, outsourcing, and off-shoring
have created an environment where end-to-end supply chains include many players, with a shared need for accurate and timely
information. (...)
Excerpt related to
fda validation compliance:
Today's enterprise is no longer a single, vertically integrated organization. Globalization, outsourcing, and off-shoring
have created an environm...
Published:
2005-12-23
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Abstract:
Dive into the state-of-the-art enterprise resource planning solutions. Performe a free gap analysis to determine the need
of upgrading your erp system. As your company grows, you must continually evaluate whether your work processes and IT solutions
can solve your problems and help grow your business. By (...)
Excerpt related to
fda validation compliance:
Do You Need a State-of-the-art ERP Solution? Source: Sage. Document Type: White Paper Description: As your company grows,
you must ...
Published:
2010-07-13
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Abstract:
SSI shows deep understanding of the requirements for chemical, drug, and mill-based industries. Consequently, it has developed
such must-have capabilities as potency controls, container movements, top-down and bottom-up traceability, and controls for
customs and excise, shelf life, and location validatio (...)
Excerpt related to
fda validation compliance:
SSI shows deep understanding of the requirements for chemical, drug, and mill-based industries. Consequently, it has developed
such must-have capa...
Published:
2006-07-25