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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...
Avoiding the Compliance Trap for Travel and Expenses
Maximizing transparency and control over travel and expense (T&E) management is essential in a compliant-conscious market. Purpose-built software and on-demand

fda compliance officer medical  the Compliance Trap for Travel and Expenses Maximizing transparency and control over travel and expense (T&E) management is essential in a compliant-conscious market. Purpose-built software and on-demand services are part of a best-practices approach that help with not only streamlining your processes, but also analysis and reporting. Find out what you need to know about automated T&E solutions—and how they can help you reduce your risk of noncompliance. 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 compliance officer medical  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 requirements, achieving compliance can be difficult and costly. One of the biggest challenges that organizations face today is reducing costs from fines and lawsuits. Download this white paper to find out how a learning management compliance solution can help manage your compliance requirements. 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 compliance officer medical  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...
Ascending the Maturity Curve: Effective Management of Enterprise Risk and Compliance
The governance, risk, and compliance (GRC) concept remains as relevant as ever. In addition to the traditional goal of meeting compliance obligations, companies

fda compliance officer medical  the Maturity Curve: Effective Management of Enterprise Risk and Compliance The governance, risk, and compliance (GRC) concept remains as relevant as ever. In addition to the traditional goal of meeting compliance obligations, companies today see the investment in risk and compliance management as a means of aligning their risk and controls with broader strategic goals, building better relationships with stakeholders, and enhancing overall performance. Read this white paper for survey finding and 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...
The Challenges of Defining and Managing Governance, Risk Management, and Compliance
A broader, more structured approach is needed to effectively manage governance, risk management, and compliance (GRC). Enterprises will then be better able to

fda compliance officer medical  recommended. For instance, the FDA regulations for drug manufacturers are not fixed targets. Thus, compliance is a key objective for any regulated drug manufacturing company, but the requirements to meet compliance are subjective based upon product, production processes, and (perhaps most important) every company's tolerance for risk. Regulatory risk is the risk of being found out of compliance, and if a company accepts very limited risk, its cost of compliance will logically be high. Conversely, with Read More...
Electronic Medical Records: An Introduction
Electronic medical records (EMR) serves a niche market. This software caters specifically to health care professionals working in clinics, private practices

fda compliance officer medical  electronic medical records,EMR,EMR systems,paper health records,health care industry,health care organizations,health care system,patient data,medical history,medication list,family history,Institute of Medicine,compliance,voice recognition system,Health Insurance Portability and Accountability Act Read More...
LogRhythm and SOX Compliance
In order for a business to stay on top of compliance requirements required by the Sarbanes-Oxley Act (SOX)—and avoid financial penalties or possible jail time

fda compliance officer medical  and SOX Compliance In order for a business to stay on top of compliance requirements required by the Sarbanes-Oxley Act (SOX)—and avoid financial penalties or possible jail time—it must take a good look at its IT environment and financial reporting processes. The collection, management, and analysis of log data are integral to meeting SOX requirements and as such, require a system that automates these processes across the IT infrastructure. Read More...
HIPAA-Watch for Security Speeds Up Compliance Part Two: Phase III and IV, and Product and User Recommendations
Once the user defines compliance case boundaries and establishes the data criteria in Phases I and II, the HIPPA-Watch for Security tool begins Phase III by

fda compliance officer medical  Watch for Security Speeds Up Compliance Part Two: Phase III and IV, and Product and User Recommendations HIPAA-Watch for Security Speeds Up Compliance Part Two: Phase III and IV, and Product and User Recommendations Featured Author - Laura Taylor - August 28, 2004 Introduction The HIPPA-Watch for Security tool was developed by RiskWatch a company founded in Maryland (US) in 1993. The tool is designed to aid companies through US risk analysis to eventual US regulatory compliance. Its risk analysis engi Read More...
A Road Map to Electronic Medical Record System Implementation
It’s crucial to define the scope of an electronic medical system implementation, as well as to outline each stage of the project and the resources that will be

fda compliance officer medical  electronic medical record system,EMR,electronic medical record software,electronic medical record solution,health care organization,patient data,EMR implementation,work breakdown schedule,WBS,human resources,HR,request for proposal,RFP,implementation methodology,project management team Read More...
Profiting from PCI Compliance
Although the Payment Card Industry Data Security Standard (PCI DSS) has become a global requirement, many organizations are lagging in compliance. For many

fda compliance officer medical  from PCI Compliance Although the Payment Card Industry Data Security Standard (PCI DSS) has become a global requirement, many organizations are lagging in compliance. For many companies, regulatory compliance can already be an overwhelming and confusing area to navigate, and the need to comply with the PCI DSS might feel like yet another burden. Discover the efficiency gains of building a strategy designed around PCI compliance. 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...
Compliance and Traceability in Manufacturing
Manufacturers focus on compliance and traceability initiatives for a variety of reasons, including compliance to regulatory mandates and mitigating risk of

fda compliance officer medical  and Traceability in Manufacturing Manufacturers focus on compliance and traceability initiatives for a variety of reasons, including compliance to regulatory mandates and mitigating risk of product recalls. Companies are increasingly focused on reducing manufacturing costs and particularly the cost of poor quality with end-to-end traceability of product and processes. Read here to know the key capabilities that help compliance and traceability initiatives. Read More...

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