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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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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 » dmr fda compliance expectations


Enhancing Governance, Risk, and Compliance through Effective Access Risk Management
Regardless of the size of the organization, embedding governance, risk, and compliance (GRC) management into all business process is imperative. But most

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Improving Regulatory Compliance with Encryption
As a bedrock element of any sound corporate data protection strategy, encryption protects valuable company data, whether it is at rest, in transit, or in use

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How to Prevent Data Leaks and Achieve PCI Compliance
The greatest threat on the Internet involves increased data theft, data leakage, and targeted attacks for the purpose of stealing confidential information. To

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Meet PCI DSS Compliance Requirements for Test Data with Data Masking
Whether you’re working toward your first or your next payment card industry (PCI) data security standard (DSS) audit, you know compliance is measured on a

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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

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Leverage Your Financial System to Enable Sarbanes-Oxley Compliance: An Evaluator’s Guide
When it comes to US Sarbanes-Oxley Act (SOX) compliance, the role of financial information systems simply cannot be overlooked. This was recently underscored by

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Paths out of the Compliance Quagmire: Plugging a Multibillion-dollar Hole
Preventable deductions are a major source of frustration and cost for suppliers, while the compliance violations that trigger them are likewise frustrating and

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SAP Lowers Revenue Expectations
Business applications vendor PeopleSoft took aim at the customer relationship management (CRM) market on October 11 as it announced plans to buy Vantive, a

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Ensuring Enterprise-wide Compliance
Complying with the Fair Labor Standards Act (FLSA), the Family Medical Leave Act (FMLA), and other labor laws and regulations is a major challenge for employers

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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

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Regulatory and Compliance Software Evaluation Report
The Regulatory and Compliance Knowledge Base covers the requirements for ensuring products and their associated materials comply with both external and intenal

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4 Key Steps to Automate IT Security Compliance
An unprecedented wave of security breaches has led to the establishment of technical standards, IT governance frameworks and laws designed to improve and

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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

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Guide to Tax Collection Compliance: Ending the Nightmare
In mid-market report: the changing face of sales and use tax compliance, find out just how bad the problem has become, and what midsized companies ...

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