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Managing Compliance with 21 CFR Part 11
Compliance with regulatory requirements is a business-critical need you must maintain. But meeting this need is more challenging with the creation of new

21 cfr part 11 compliance  Compliance with 21 CFR Part 11 Compliance with regulatory requirements is a business-critical need you must maintain. But meeting this need is more challenging with the creation of new regulations, such as 21 CFR Part 11, governing the use of software for secure data processing. But compliance is possible: an enterprise resource planning (ERP) system can help with audits, document and digital signatures, validation scripts, and other security needs. 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 » 21 cfr part 11 compliance


Governance, Risk, and Compliance for Life Sciences Companies: Institutionalize Compliance to Reduce Costs and Increase Productivity
Issues of governance, risk, and compliance (GRC) affect nearly everything life sciences companies do. But you shouldn’t approach GRC in an ad hoc manner

21 cfr part 11 compliance  (cGxP) and the FDA's 21 CFR Part 11, which sets down requirements for establishing audit trails for electronic documents. To combat counterfeiting, companies must introduce electronic pedigree controls. The SAP GRC Access Control application ensures SOD compliance for cGMP between different areas of operation, for example, production and quality management. Powered by SAP NetWeaver, SAP solutions for GRC ease compliance with Part 11 requirements for documentation and auditability, while providing a Read More...
Oracle Renders Its PLM Outline Part One: Event Summary
Although its PLM solutions will not likely be the

21 cfr part 11 compliance  and Drug Administration's [FDA] 21 CFR Part 11 regulation), Health Insurance Patient Portability Act (HIPAA), a guideline for managing patient information, and Sarbanes-Oxley Act (SOA), the new legislation for accounting procedures, while the Oracle Financials suite also now leverages eXtensible Business Reporting Language (XBRL), and XML-based standard for financial reporting. Also, rather than traditionally delivering a horizontally broad and functional product and relying on its technically savvy Read More...
Market Insight: Strategies for Overcoming Compliance Issues in the Pharmaceutical Industry
To successfully meet compliance demands, pharmaceutical manufacturers must develop, implement, and track the effectiveness of a company-wide compliance strategy

21 cfr part 11 compliance  audit trails required by 21 CFR Part 11 and other current Good Manufacturing Practices (cGMP), and also utilizes a SQL Server® database to insure data integrity and prevent data corruption. Source: Deacom, Inc. Resources Related to Market Insight: Strategies for Overcoming Compliancy Issues in the Pharmaceutical Industry : Compliance (Wikipedia) Strategy (Wikipedia) Market Insight: Strategies for Overcoming Compliancy Issues in the Pharmaceutical Industry Compliance Strategy is also known as : Read More...
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

21 cfr part 11 compliance  to FDA’s publication in 21 CFR 820.40, Medical Device Manufacturers are required to have written procedures for the approval and distribution of documents. The approval procedures must ensure that the documents meet the requirements of the QS/GMP as well as adequacy for their intended use. Obsolete documents must be removed from circulation, and document approvals must include a signature and date. Removal (or prevention of use) of obsolete documents must also be verified. Written procedures Read More...
ITAR Compliance with SAP GTS
If you deal in goods, services, or intellectual property included in the US Munitions List, you must ensure that all related transactions conform to

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Getting a Return on Supply Chain Compliance
Change your paradigm by using supply chain compliance as a competitive tool to grow your business.  By viewing your organization from the inside out, you’ll

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Info360 - the Information Management Event of the Year -- March 21-24 in Washington, DC
Learn how at the info360 Conference and Expo, March 21-24 in Washington, DC.

21 cfr part 11 compliance  the Year -- March 21-24 in Washington, DC Info360 - the Information Management Event of the Year -- March 21-24 in Washington, DC Looking for ways to improve your company's business processes, collaboration, knowledge sharing, and decision making? Learn how at the info360 Conference and Expo , March 21-24 in Washington, DC. Register now and pay nothing. Learn about the latest solutions from scores of software and hardware vendors and service providers. And attend seminars and workshops on the hottest Read More...
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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To SaaS or Not, Is That a Question? - SaaSy Discussions (Part IIc)
The first part (Part II) of this blog series described the opportunities for software as a service (SaaS) or on-demand applications, especially in the current

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How to Achieve Compliance with Payment Cards
Data auditing and data encryption are two key Payment Card Industry (PCI) requirements for maintaining cardholder data protection. Although the two capabilities

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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

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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

21 cfr part 11 compliance   Read More...

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