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Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance
The US Food and Drug Administration (FDA) requires pharmaceuticals and medical device companies to comply with numerous standards. Medical device manufacturers

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Web Content Management (WCM)
Web content management (WCM) systems manage content creation, review, and approval processes for web site content. This may include public Web sites (Internet) or private web sites (intranet or ext...
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Documents related to » fda approval guidelines


Market Insight: Strategies for Overcoming Compliance Issues in the Pharmaceutical Industry
To successfully meet compliance demands, pharmaceutical manufacturers must develop, implement, and track the effectiveness of a company-wide compliance strategy

fda approval guidelines  Restrictions These criteria address FDA requirements for pharmaceutical and food manufacturing companies, including: Protect records to enable their ‘accurate and ready retrieval' ; Use computer-generated, time-stamped audit trails to record the date and time of record creation, modification, or deletion ; and Establish authority checks to ensure only authorized personnel can access the system and electronically sign or alter a record. Different administrators for different areas of workforce Read More...
Automotive Industry and Food, Safety, and Drug Regulations
Enterprise application providers wanting to address the distinct regulatory requirements of the automotive, food, safety, and life sciences industries need to

fda approval guidelines  supports its mission, the FDA has defined good manufacturing practices (GMPs). Originally, GMPs were based on the best practices of the industry, and as technology and practices improved, the GMPs evolved as well. For instance, in the US, drug GMPs were formally introduced in 1963 and were significantly rewritten in the 1970s. GMPs define a quality system that drug manufacturers must use as they build quality into their products. For example, approved drug products that have been developed and produced Read More...
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, you have operational

fda approval guidelines  supports its mission, the FDA has defined Good Manufacturing Practices (GMPs) . Originally, GMPs were based upon the best practices of the industry. As technology and practices improved, the GMPs evolved as well. In the U.S., drug GMPs were formally introduced in 1963 and significantly rewritten in the 1970s. GMPs define a quality system that manufacturers use as they build quality into their products. For example, approved drug products developed and produced according to GMPs are safe, properly Read More...
Make the Safe Choice
When it comes to workers’ safety, companies shouldn’t take any chances. The growing safety, security, and regulatory and reporting requirements are forcing many

fda approval guidelines   Read More...
Web Content Management (WCM) Software Evaluation Report
Web content management (WCM) systems manage content creation, review, and approval processes for web site content. This may include public Web sites (Internet),

fda approval guidelines  Content Management (WCM) Software Evaluation Report Web content management (WCM) systems manage content creation, review, and approval processes for web site content. This may include public Web sites (Internet), or private web sites (intranet or extranet). Use a WCM solution to organize and manage documents; provide content version control, collaboration utilities, and user or document level security. Read More...
Vulnerability Management for GLBA Compliance
The security provisions of the US Gramm-Leach-Bliley Act (GLBA) are complex and process-intensive, and non-compliant financial institutions and their officers

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Applying Lessons Learned in CRM Projects
The road to implementing customer relationship management (CRM) systems is fraught with risk and littered with failure. Paradoxically, reams have been written

fda approval guidelines   Read More...
Making SOP Training More Effective
Standard Operating Procedures (SOPs) are critical to efficient operations, quality control, and regulatory compliance. Yet many recent FDA violations have

fda approval guidelines  compliance. Yet many recent FDA violations have focused on firms’ failure to properly use SOPs. This paper reviews best practices for the life science industry for training on SOPs. Specifically, how the latest learning management technology has the potential to improve learner retention through automated assessments. Read More...
LaserComp
LaserComp can help to simplify compensation management for the enterprise. It enables compensation analysts to create plans, model impact, manage approval

fda approval guidelines  lasercomp,lasercomp software,employee compensation software,incentive compensation software,workers compensation software,hr compensation software,sales compensation software Read More...
Document Imaging: Where to Begin
Perhaps the most-asked question when considering document management solutions is “How do I scan my paper documents quickly and efficiently?” Companies

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Technology Enablers for the Lean Supply Chain
Transforming an enterprise to a lean supply chain requires both enabling technology and discipline. By following some specific guidelines to extend lean

fda approval guidelines  lean,lean manufacturing,supply chain management,SCP,enterprise resource planning,ERP,supply chain visibility,SCV,supply chain event management,SCEM Read More...
Even If We Knew Who You Are, We Probably Wouldn’t Tell
Companies specializing in personalization of consumer relationships have formed a consortium and conducted their first research study. The conclusion is that

fda approval guidelines  personalization,consortium,personalization technology,Personalization Consortium,self-regulation guidelines,government regulation,DoubleClick,DoubleClick's technology,B2C e-commerce,personalization tools Read More...
RealExchange
Functionality that streamlines the entire purchasing process for improved management and tracking of spend:- Requisitioning - state of the art content search

fda approval guidelines  Functionality that streamlines the entire purchasing process for improved management and tracking of spend:- Requisitioning - state of the art content search engine provides rapid search results from more than 4 million SKUs. Click and buy functionality helps requisition goods.- Approval workflow - customizable workflow functionality to establish rules and parameters for greater control.- Order Management - complete line-level tracking and automated notifications for greater visibility into Read More...
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