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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


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
HIPAA-Watch for Security Speeds Up Compliance Part One: Vendor and Product Information
HIPAA-Watch for Security is a tool designed to guide organizations through the risk analysis required by the Health Insurance Portability and Accountability Act

21 cfr part 11 compliance  Suite 300, Annapolis, MD, 21401 Product Name HIPAA-Watch for Security Key Features NIST 800-26 compliant, automatic reporting, auditing, multi-user response system, life cycle management, automated financial calculations: annual loss expectancy, cost benefit analysis, return on investment; customizable Company URL www.riskwatch.com Product URL www.riskwatch.com/hipaa.asp Customer Contact 800-448-4666 Investor Inquiries invest@riskwatch.com This is Part One of a two-part note. Part One provides a vendor 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
Complying with US FDA Title 21 CFR Part 11 for the Life Sciences Industry
Compliance with US FDA regulations is a market requirement. Thus, among the nearly 1,500 installations of mySAP ERP software among pharmaceutical, medical

21 cfr part 11 compliance  with US FDA Title 21 CFR Part 11 for the Life Sciences Industry Compliance with US FDA regulations is a market requirement. Thus, among the nearly 1,500 installations of mySAP ERP software among pharmaceutical, medical diagnostics and devices, and biotechnology companies worldwide, it is vital to be aware of the functions and features of mySAP ERP that demonstrate technical compliance with US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule. Read More
The Power of Knowledge -- Knowledge is Power (Part 2)
Part 1 of this blog series introduced the need for knowledge management (KM) software applications as part of a more comprehensive and strategic service

21 cfr part 11 compliance   Read More
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
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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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

21 cfr part 11 compliance  governance risk compliance,grc,governance risk compliance management,grc management,grc solutions,governance risk and compliance resources,grc resources,grc risk,spiraling compliance costs,it governance risk compliance,grc software strategies,cross enterprise solutions,risk management Read More
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

21 cfr part 11 compliance   Read More
Vulnerability Management for GLBA Compliance
The security provisions of the US Gramm-Leach-Bliley Act (GLBA) are complex and process-intensive, and non-compliant financial institutions and their officers

21 cfr part 11 compliance   Read More
Help Achieve Compliance Objectives with Microsoft Dynamics GP
The demands placed on executives to balance compliance requirements with those of the market have increased dramatically over the past few years. However

21 cfr part 11 compliance   Read More
Lean Manufacturing: Part Two
Part One of the

21 cfr part 11 compliance  lean manufacturing, lean principles, lean practices, inventory control, lean process ERP, kanban 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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11th ERP Vendor Shootout - Boston MA, Aug 11-12, 2011 - Early Bird Rates Extended!
Early Bird pricing extended through July 20, 2011. The 11th Vendor Shootout for ERP.

21 cfr part 11 compliance  11th erp vendor shootout boston aug 11 12 2011 early bird rates extended,11th,erp,vendor,shootout,boston,aug,early,bird,rates,extended,erp vendor shootout boston aug 11 12 2011 early bird rates extended,11th vendor shootout boston aug 11 12 2011 early bird rates extended,11th erp shootout boston aug 11 12 2011 early bird rates extended,11th erp vendor boston aug 11 12 2011 early bird rates extended. Read More

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