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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 compliance officer medical  ERP/CRM Software to Facilitate FDA Compliance Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. With more than 30 years' history and as one of the first software vendors to develop an enterprise resource planning (ERP) solution, SYSPRO is the longest standing and largest independent, international vendor of enterprise business solutions. Source : Read More

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 compliance officer medical


Catching Up with Omnify Software
In the deluge of news revolving mainly around the Big Five product lifecycle management (PLM) vendors, i.e., Siemens PLM, Dassault Systemes, Parametric

fda compliance officer medical  it be for the FDA, ISO, or FAA, etc., and they all need a way to meet the requirements as well as ease the compliance and audit processes. Because regulatory compliance typically requires tracking/traceability and reporting of product related data, PLM provides a very good foundation to manage this. PJ : What is your collaborative E2.0/social tools strategy? Any views on Dassault's Exalead acquisition? CC : We continue to encompass more social media concepts into our tool suite. Our current focus is to Read More
Are You on Track for 21 CFR Part 203 Compliance?
It’s old, it’s new, and it’s the future. Pedigree tracking regulations were originally passed into law through the Prescription Drug Marketing Act of 1987 (PDMA

fda compliance officer medical  Food and Drug Administration (FDA) has lifted its final stay. Pharmaceutical companies are expected to be in compliance with 21 CFR Part 203 by the year 2011. Do you have what it takes for compliance? Read More
Top 5 HR Compliance Concerns for Small Business
Small and medium-sized companies can be so focused on core business issues that they overlook one of their most potentially serious and costly issues—human

fda compliance officer medical  5 HR Compliance Concerns for Small Business Small and medium-sized companies can be so focused on core business issues that they overlook one of their most potentially serious and costly issues—human resource compliance. They often lack the time and resources to build infrastructure and processes that are beyond core business objectives. This paper discusses the top small business compliance concerns. Read More
Implementing Basel II in the Compliance Continuum
Banks can benefit enormously from understanding the various stages of the Basel II compliance program, as identified by i-flex. Banks today are discovering

fda compliance officer medical  Basel II in the Compliance Continuum Banks can benefit enormously from understanding the various stages of the Basel II compliance program, as identified by i-flex. Banks today are discovering problems as they stumble along the path to compliance. However, if they can benchmark themselves on which stage they fall in along the continuum, and buckle themselves for the challenges that lie ahead, they will have greater success towards Basel II compliance, and enjoy the benefits of maintaining 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 compliance officer medical  Financials for Improved Business Value and Compliance If your company uses disparate software systems, spreadsheets, and manual workarounds to drive financial outcomes, you may be stifling your business. In Align Financial Processes and Systems for Better Business Value and Compliance , learn how an integrated, life-cycle approach to financial management can dramatically improve your financial analysis, performance, and reporting. You'll discover how the right financial approach can help you gain Read More
An Enterprise Approach to Sarbanes-Oxley Compliance
As is generally the case with such issues as the US Sarbanes-Oxley Act (SOX), the quick fix is often too good to be true. Leading companies are thus using SOX

fda compliance officer medical  Enterprise Approach to Sarbanes-Oxley Compliance As is generally the case with such issues as the US Sarbanes-Oxley Act (SOX), the quick fix is often too good to be true. Leading companies are thus using SOX as an opportunity to restructure the way they run their business. What’s more, they’re finding they already have much of what they need—including the right people, processes, and technology. Read More
Governance, Regulation and Compliance
Companies must meet GRC criteria defined by internal and external policies, as failing to do so can have business and legal consequences. Although management of

fda compliance officer medical  Regulation and Compliance Companies must meet GRC criteria defined by internal and external policies, as failing to do so can have business and legal consequences. Although management of travel and entertainment (T&E) expenses is often seen as being of low importance for overall GRC, poorly managed T&E can lead to unforeseen issues with long-term business impact. See why using an external T&E management provider is the best way to adhere to GRC. Read More
Avoiding Information Overload: A Logical Approach to Managing Endpoint Security and Compliance
One of the biggest issues now facing corporations is regulatory compliance. As if corporate security threats weren’t enough, regulations such as Sarbanes-Oxley

fda compliance officer medical  Information Overload: A Logical Approach to Managing Endpoint Security and Compliance One of the biggest issues now facing corporations is regulatory compliance. As if corporate security threats weren’t enough, regulations such as Sarbanes-Oxley (SOX), the Gramm-Leach-Bliley Act (GLBA), and others now have long checklists of mandated requirements that must be adhered to—and thoroughly documented—by IT departments. Learn about a logical approach to managing the volumes of data required to Read More
Validate and Enforce Change Process for SOX Compliance
If the auditors came knocking, would you be prepared? When they do come, you’ll need to be ready to answer some tough questions regarding your change management

fda compliance officer medical  and Enforce Change Process for SOX Compliance If the auditors came knocking, would you be prepared? When they do come, you’ll need to be ready to answer some tough questions regarding your change management processes. Implementing and assessing change management controls for Sarbanes-Oxley Act (SOX) compliance in the US can be a very expensive and time consuming process. Find out how you can reduce the SOX burden by improving the way you manage your change processes. Read More
Sarbanes-Oxley Compliance with ERP Software
For many companies, enterprise resource planning (ERP) is the single most important infrastructure element, thanks largely to its power in delivering end-to-end

fda compliance officer medical  Oxley Compliance with ERP Software For many companies, enterprise resource planning (ERP) is the single most important infrastructure element, thanks largely to its power in delivering end-to-end integration. New technology in ERP software has grown in sophistication over the years, enabling even further automation of business functions. Find out how you can leverage one ERP solution to deal with one of your biggest bugbears: Sarbanes-Oxley compliance. Read More
The Age of Compliance: Preparing for a Riskier and More Regulated World
The three themes of governance, risk, and compliance (GRC) have been central to the management agenda for a decade. But whereas years ago it was the “C” in GRC

fda compliance officer medical  Age of Compliance: Preparing for a Riskier and More Regulated World The three themes of governance, risk, and compliance (GRC) have been central to the management agenda for a decade. But whereas years ago it was the “C” in GRC that kept executives awake at night (and indeed was the impetus behind the development of GRC in the first place), in the post-crisis world it is the “R” that has risen to the top of the agenda. Learn about a more efficient approach to managing risk and compliance. Read More
Provia Tackles RFID in a Twofold Manner Part Two: RFID Compliance
Provia's approach to radio frequency identification (RFID) compliance was to offer a bolt-on or drop-in product that works in conjunction with a company's

fda compliance officer medical  Tackles RFID in a Twofold Manner Part Two: RFID Compliance RFID Compliance These days when radio frequency identification (RFID) is constantly on everyone's lips, and when every relevant enterprise application vendor is hedging its bets towards becoming RFID-ready or is even convincing the market that its RFID-compliant solution is exactly what the doctor ( Wal-Mart , Target , Albertsons , and the US Department of Defense [ DoD ]) ordered, the typically quiet Provia Software ( www.provia.com ), a 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 compliance officer medical  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 can you address the requirement for shared privileged access while still maximizing information security? Find out how traditional solutions may not be providing the security you need—and how upgrading your password system with an automated solution can help. Read More
Managing Compliance and Access For The Cloud
You can use identity and access management to improve security, reduce risk, and meet compliance requirements for cloud systems. But are you aware of the

fda compliance officer medical  Compliance and Access For The Cloud You can use identity and access management to improve security, reduce risk, and meet compliance requirements for cloud systems. But are you aware of the identity requirements for access controls and audit for software-as-a-service (SaaS) applications? Or about the compliance regulations governing sensitive information in SaaS and cloud applications? Discover how to address the needs of SaaS and cloud-based identities. Read More

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