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 21 cfr part 11 compliance


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.

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Software Functionality Revealed in Detail

We’ve opened the hood on every major category of enterprise software. Learn about thousands of features and functions, and how enterprise software really works.

Get free sample report
Compare Software Solutions

Visit the TEC store to compare leading software by functionality, so that you can make accurate and informed software purchasing decisions.

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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 requirements needs, as well as product related components of environmental health and safety (EH&S). 

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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


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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


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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

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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

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