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Documents related to » fda


Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance
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 with numerous standards. Medical device manufacturers have long embraced enterprise resource planning (ERP) and customer relationship management (CRM), but primarily use them to achieve operational efficiencies. However these systems can play a significant role in their abilities to comply with strictly FDA regulations.

FDA:
3/14/2006 10:41:00 AM

A Quality and Compliance Training Road Map for Emerging FDA-regulated Companies
A Quality and Compliance Training Road Map for Emerging FDA-Regulated CompaniesEmerging life science companies face the same compliance and regulatory pressures as larger ones. Companies that outsource sales and operational functions need to disseminate training on key policies, procedures, and regulations to a wide audience—without the benefit of a dedicated training team. These companies demand solutions that automate the quality training effort without compromising the entire quality program.

FDA: training, learning management, lms, learning management system, learning management systems, open source learning management system, learning management system lms, learning management system software, online learning management system, learning management systems comparison, learning management system comparison, e learning management system, learning management system open source, lms learning management system, learning systems management, best learning management system, a learning management system, learning management system features, web based learning management system, learning .
6/12/2012 4:13:00 PM

Complying with US FDA Title 21 CFR Part 11 for the Life Sciences Industry
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 technical compliance with US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule.

FDA:
11/23/2006 4:11:00 PM

A Quality and Compliance Training Road Map for Emerging FDA-regulated Companies
A Quality and Compliance Training Road Map for Emerging FDA-Regulated CompaniesEmerging life science companies face the same compliance and regulatory pressures as larger ones. Companies that outsource sales and operational functions need to disseminate training on key policies, procedures, and regulations to a wide audience—without the benefit of a dedicated training team. These companies demand solutions that automate the quality training effort without compromising the entire quality program.

FDA: training, learning management, lms, learning management system, learning management systems, open source learning management system, learning management system lms, learning management system software, online learning management system, learning management systems comparison, learning management system comparison, e learning management system, learning management system open source, lms learning management system, learning systems management, best learning management system, a learning management system, learning management system features, web based learning management system, learning .
6/12/2012 4:13:00 PM

The Many Faces of PLMPart Two: The Future of the PLM Suite
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 this more mature solution will result in a broad suite of focused, integrated applications that leverage a core of unified, structured product data - the PLM Platform.

FDA:
12/30/2003

Do You Need a State-of-the-art ERP Solution?
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 performing a gap analysis, you can look at where your business is headed and whether you have the right tools to get there. This white paper can help you perform a preliminary gap analysis to determine whether you need to upgrade your IT solutions and business processes.

FDA: Sage, erp, erp software, erp system, gap analysis, enterprise resource planning, erp crm, erp implementation, software evaluation, erp systems, software selection, what is erp, erp enterprise, erp planning, erp project, enterprise resource planning erp, erp integration, erp mrp, web erp, baan erp, erp companies, erp training, erp company, erp modules, erp application, erp consulting, erp module, erp process, erp cost, implementing erp, small business erp, erp applications, erp comparison, erp technology, free erp software, implementation of erp, online erp, enterprise resource planning .
7/13/2010 12:16:00 PM

Fighting Terrorism with Global Trade Management
The challenge for government and industry is to secure trade without impeding growth. Therefore, there is a greater need for timely information updated by knowledgeable sources of compliance and regulation issues. Global trade management software appears to be the best solution.

FDA: global trade management, GTM, security, 9/11, customs, US Department of Homeland Defense, 24-Hour Automated Manifest Rule, Container Security Initiative, Customs-Trade Partnership Against Terrorism (C-TPAT), Operation Safe Commerce, US Customs.
6/15/2005

Process-based Governance, Risk Management, and Compliance
The right balance of automated processes with paper records and manual, human interaction is necessary to keep costs under control with a flexible yet controlled set of procedures. The strategic software category, governance, risk management, and compliance, is poised to help.

FDA: governance, risk management, compliance, GRC, process-based GRC, Sarbanes-Oxley Act, SOX, regulatory compliance, business risk, information technology, IT, Kiran Garimella, business process management, BPM, Control Objectives for Information and Related Technologies, COBIT, control tests, service oriented architecture, SOA, model-driven architecture, MDA, business activity monitoring.
7/23/2008

Is There a Panacea for Enterprise Software Pricing Yet?
While enterprise applications are becoming a commodity, their pricing schemes have yet to follow suit. Users are put in a costly position where the

FDA: enterprise, solutions, implementation, cost, service and maintenance, warranties, development.
12/21/2005

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 offer enterprises industry-oriented enterprise resource planning systems that are sound and compliance-ready.

FDA: regulatory compliance, GRC, governance, risk management, and compliance, ERP, enterprise resource planning, automotive industry, enterprise applications systems, TREAD Act, International Standards Organization, ISO, product lifecycle management, PLM, advanced product quality planning, APQP, products part approval process, PPAP, Failure Modes and Effects Analysis, FMEA, FDA, US Food and Drug Administration, US Department of Agriculture, USAD, US Centers for Disease Control, CDC, traceability requ.
3/2/2007


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