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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

fda regulatory compliance consultants  Medical Device Compliance , FDA Regulatory Compliance , FDA Requirements , Food and Drug Administration FDA , Medical Regulatory Compliance , Regulatory Compliance , Regulatory Compliance Software , FDA Policy , FDA Compliance Consulting . While every manufacturer in the United States is subject to a multitude of governmental rules and regulations, probably no industries are as fully regulated as those dealing with pharmaceuticals and medical devices. The U.S. FDA (Food and Drug Administration) requires Read More...
Regulatory and Compliance
Regulatory compliance covers the requirements for ensuring products and their associated materials comply with both external and internal rules and regulations. It covers regulatory and requirement...
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Documents related to » fda regulatory compliance consultants


Mid-Market Strategy: International Enterprise Solutions
Adonix marks its strategy with two catchwords:

fda regulatory compliance consultants  Food and Drug Agency-registered (FDA) manufacturers comply with regulatory requirements imposed by legislation such as the Bioterrorism Act and 21 CFR Part 11. It is ideally suited for companies producing coatings, adhesives, and sealants, as well as other batch-produced products. Since Adonix X3 also has solid discrete manufacturing capabilities to complement its process manufacturing orientation, it may also allow some mixed-mode manufacturing environments to freely adapt their systems to the style of Read More...
Ross Systems' Focus Yields More Value For Process Manufacturers
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

fda regulatory compliance consultants  using iRenaissance have achieved FDA validation and Ross will soon be offering more specific validation applications to help customers in their FDA validation efforts. Cambrex is a life sciences company with 100's of unique products and thousands of customers ranging from individual research scientists to large corporations. At Cambrex, responsive customer service requires highly skilled customer service representatives (CSR's). Using the iRenaissance Customer Portal, Cambrex is improving customer Read More...
Do You Need a State-of-the-art ERP Solution?
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

fda regulatory compliance consultants  following capabilities for meeting FDA demands? Does your system fully integrate all material planning processes and centrally capture traceability data? Does it support both forward traceability from ingredients to customer shipments and backward traceability from customer shipments to manufactured lots, and finally to ingredients or components received from suppliers? Does your system track lot properties, grades, and testing results? Does it include user-defined technical sheets and operational detail Read More...
The Name and Ownership Change Roulette Wheel for Marcam Stops at SSA Global Part Two: Marketing By Invensys
IPS was hoping that the early product vision and venerable reputation that Marcam has in the process manufacturing market for providing plant-centric ERP

fda regulatory compliance consultants  necessary processes to achieve FDA certification. Because of the growing regulatory requirements, enterprises with legacy ERP instances have been demanding that their vendors extend their depth in areas such as 21 CFR 11 Part 11, which was introduced to anticipate the effects of electronic technology' on the drug discovery, development, and manufacturing processes. Accordingly, FDA regulations focus on two areas: 1) electronic records (i.e., ensuring accuracy, reliability, consistency, and visibility to Read More...
Don’t Let Wireless Detour Your PCI Compliance
The Payment Card Industry Security Standards Council (PCI SSC) has published a PCI DSS Wireless Guideline which acknowledges that wireless is a clear and

fda regulatory compliance consultants   Read More...
Regulatory and Compliance RFI/RFP Template
Design for Compliance,Management of Hazardous and Controlled Substances,Regulatory and Compliance Documentation,Managing Recyclables and Controlled

fda regulatory compliance consultants  and Compliance RFI/RFP Template Design for Compliance, Management of Hazardous and Controlled Substances, Regulatory and Compliance Documentation, Managing Recyclables and Controlled Waste, Product Technology Read More...
Compliance and Privileged Password Management
Today’s increasing compliance requirements have focused additional attention on how enterprises manage and control these critical accounts and passwords. How

fda regulatory compliance consultants   Read More...
The Value of a Learning Management Compliance Solution
Companies spend millions each year conducting mandatory training. Whether triggered by an audit, the risk of non-compliance, bad PR, or internal training

fda regulatory compliance consultants  SumTotal,government,learning management,learning management software,learning management solution,learning management solutions,learning management system,learning management system lms,learning management systems,learning talent development Read More...
Proactive IT Triage for Sarbanes-Oxley Compliance
When it comes to Sarbanes-Oxley compliance, most IT organizations do not lack measurement data—in fact, they’re buried in it! What they need are effective ways

fda regulatory compliance consultants   Read More...
Streamlining Regulatory Publishing with Submission-ready PDFs
Many companies spend an inordinate amount of time and money ensuring their documentation meets regulatory standards. But in order to streamline the document

fda regulatory compliance consultants  Regulatory Publishing with Submission-ready PDFs Many companies spend an inordinate amount of time and money ensuring their documentation meets regulatory standards. But in order to streamline the document submission process in a cost-effective manner, companies should adopt document management technologies coupled with collaborative document transformation tools. Learn how these tools can help your company accelerate its submission-compliant document workflows. Read More...
ERP Selection Series: Requirements for an FDA-regulated Environment
The FDA imposes strict process controls on food and pharmaceutical manufacturers for good reason. Consequences of mistakes are hefty—ranging from costly recalls

fda regulatory compliance consultants  an FDA-regulated Environment The FDA imposes strict process controls on food and pharmaceutical manufacturers for good reason. Consequences of mistakes are hefty—ranging from costly recalls and lawsuits to illness and death. Food and pharmaceutical manufacturers need to keep profitability high while maintaining strict quality-control standards. See how your ERP software can make the difference between process control and business-crippling process instability. Read More...
Governance, Risk, and Compliance Management
Governance, risk, and compliance (GRC) issues are hot topics today, thanks to high-profile stories about companies that failed to meet regulatory requirements

fda regulatory compliance consultants  Risk, and Compliance Management Governance, Risk and Compliance Management: Realizing the Value of Cross-Entreprise Solutions If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. Founded in 1972, SAP has a rich history of innovation and growth as a true industry leader. SAP currently has sales and development locations in more than 50 countries worldwide and is listed on several exchanges, including the Frankfurt Stock Exchange Read More...
How a Leading Vendor Embraces Governance, Risk Management, and Compliance
SAP AG has long committed to placing compliance at the core of its product suite, as the vendor has recognized the growing role of enterprise systems in

fda regulatory compliance consultants  Food and Drug Administration (FDA) requirements for pharmaceutical companies; and Basel II for the banking sector. This is part one of the two-part article How a Leading Vendor Embraces Governance, Risk Management, and Compliance . In part two, SAP's GRC product suite will be discussed in more detail, and speculation will be made on the product suite's potential for success within the vendor's current and prospective customer base. Read More...
Providing a Foundation for Regulatory Compliance
Regulations regarding digital information use, storage, and protection are meant to help maintain the integrity and security of public and private networks

fda regulatory compliance consultants  a Foundation for Regulatory Compliance Regulations regarding digital information use, storage, and protection are meant to help maintain the integrity and security of public and private networks. Compliance measures such as the payment card industry (PCI), the Gramm-Leach-Bliley Act (GLBA), and others focus on the long-term retention and integrity of all data. Achieving secure, long-term data retention is easier with log management and incident response tools. Read More...

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