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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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Electronic Medical Records (EMR) for the Health Care Industry
Electronic Medical Records (EMR) assists physicians and other clinicians document patient care for current visits and provides access to patient clinical history. Sometimes may be referred to as co...
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Documents related to » fda food compliance medical


Not Yet Sold on SaaS ERP in Manufacturing? Take a Hard Look at Plex Online - Part 2
Part 1 of this blog series explained Plex Systems’ ebullience and growth despite a hostile and depressed environment, especially in the discrete manufacturing

fda food compliance medical  There has been no FDA guidance issued on SaaS yet. Other issues and caveats would stem from the dubious validation of software that is outside the manufacturer’s physical control in spite of the additional power and accessibility of a SaaS system. SaaS applications must be built with full redundancy, backup, and failover so that the risk of data loss is reduced to as close to zero as possible. To that end, Plex is happy to submit itself to the customer’s qualification of it as an approved vendor. Read More
Global Trade and the Role of Governance, Risk Management, and Compliance Software
The growing number of legal and regulatory requirements associated with global trading is one of many reasons enterprises are looking into global trade

fda food compliance medical  As an example, the FDA is permitting manufacturers to benefit from emerging technologies to streamline record keeping and compliance. This technology can increase the usability of the information gathered by integrating both business processes and audit functions without compromising the quality of regulatory compliance. Thus, the opportunity to improve business practices can be significant. Potential benefits may include the following: lowered cost of data collection; increased accuracy of data; 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 food compliance medical  organizations notify the U.S. FDA before they import food products into the United States. See SAP 's Consumer Product: Regulatory Compliance for more. The regulation has created a new requirement for consumer goods manufacturers, whereby they must track the source of raw materials as well as the destination customer of the finished goods. The participants in the entire supply chain have to maintain inventory attributes, such as lot numbers, revision codes, manufacturing dates, expiration dates serial Read More
Case Study: Align Technology, Inc.
Planning to expand, Align@a medical device manufacturer@identified electronic document management as a vital component of growth. One goal was to reduce the

fda food compliance medical  Food and Drug Administration (FDA) regulations do not allow for shortcuts. We knew that investing in document management would be critical. -Len Hedge, VP Operations Align Technology, Inc.   Situation Align Technology, Inc. (NASDAQ: ALGN) is a medical device company engaged in the design, manufacture and marketing of Invisalign®, the world's leading invisible orthodontic product. Invisalign is a series of clear, removable aligners that both orthodontists and general dentists use to straighten their Read More
Cloud/SaaS is the Perfect Solution for Food and Beverage Processors
Fast becoming the preferred delivery model for companies in other manufacturing industries, software as a service (SaaS) is being adopted by food and beverage

fda food compliance medical  SaaS is the Perfect Solution for Food and Beverage Processors Fast becoming the preferred delivery model for companies in other manufacturing industries, software as a service (SaaS) is being adopted by food and beverage processing companies using inadequate management systems. See how a SaaS-based enterprise resource planning (ERP) system helps processors operate more efficiently and profitably, and enables world-class security, disaster recovery, and an expandable storage capacity. Read More
Making Data Safe for Compliance and Outsourcing
Corporate leaders know that revenues are made from “better data.” And when your data is at risk, so is the survival of your organization. That’s why it’s

fda food compliance medical   Read More
Innovating to Maximize Market Opportunities: Growing Food and Beverage Businesses
Demand for food and beverages continues to rise. The market will pay a premium for partially prepared healthier choices that are convenient and easy to eat

fda food compliance medical  to Maximize Market Opportunities: Growing Food and Beverage Businesses Demand for food and beverages continues to rise. The market will pay a premium for partially prepared healthier choices that are convenient and easy to eat anywhere, or more cost-effective for large-scale food preparation. Discover how software solutions can help companies with innovative solutions for these niche markets gain brand dominance and market loyalty, and achieve higher revenues, profits, and market share. Read More
Striking a Balance between Governance, Risk, and Compliance
Increasingly complex regulatory requirements in the health care industry have intensified pressures on health systems to assure compliance and operational

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Make Compliance Work for You
Compliance is often treated as a necessary evil that creates costs, disruption, and complexity. But these pains often result from dealing with compliance in a

fda food compliance medical   Read More
Aligning Financials for Improved Business Value and Compliance
In Align Financial Processes and Systems for Better Business Value and Compliance, learn how an integrated, life-cycle approach to financial manage...

fda food compliance medical  aligning financials improved business value compliance,aligning,financials,improved,business,value,compliance,financials improved business value compliance,aligning improved business value compliance,aligning financials business value compliance,aligning financials improved value compliance. Read More
Compliance: Is Remote Office Data Your Achilles Heel?
Would spending millions of dollars and countless hours securing your data center be enough for it to pass a compliance audit? While many businesses work hard at

fda food compliance medical   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 food compliance medical  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
Compliance Exposures in ERP Systems Part 1
This paper examines key issues for CFOs and CEOs in managing ERP systems in the new world of SOX, IFRS, Basle II. While most IT management attention seems to be

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