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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.
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 fda compliance program guidance manual


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 program guidance manual  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 :

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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.

Compare Now

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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Documents related to » fda compliance program guidance manual

Process Manufacturing: Ensuring Food Safety through Active HACCP Management


As a result of publicized food contamination and product recalls, food safety regulations are under increasing scrutiny. Process manufacturers in the food and beverage industry may soon be facing stricter rules. But food manufacturers can prevent contamination by using existing technology to automate and ensure the effectiveness of the hazard analysis and critical control point (HACCP) food safety program. Learn more.

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Supply Chain Network Visibility and Analytics


The complexity of the global economy is a powerful motivation for companies to look for new ways to increase efficiency and productivity. That’s why companies must have the ability to transform information into meaningful, accurate insights. Most importantly, these insights must be systematically interconnected, to align business strategy with tactics through a seamless integration of analytical, transactional, and collaborative processes.

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The Best-kept Secret in the Product Lifecycle Management Mid-market


The name Omnify Software may hardly come to mind when one thinks of the product lifecycle management (PLM) leaders, but that might change down the track

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IBM OpenPages Policy and Compliance Management


This video introduces the IBM OpenPages GRC Platform and, specifically, the Policy and Compliance Management module.

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The Task Bank: Crucial for a Successful “Stay at Work/Return to Work” Program


“Stay at work/return to work” (SAW/RTW) programs address workforce productivity, costs, and lost time due to medical issues. The SAW/RTW approach is a collaborative process aimed at returning an employee to full work capacity after a medical incident. The task bank—work the employee is able to perform given any medical restrictions—is a vital tool in the process. Learn how to create and manage a best-practice task bank.

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An Enterprise Approach to Sarbanes-Oxley Compliance


As is generally the case with such issues as the US Sarbanes-Oxley Act (SOX), the quick fix is often too good to be true. Leading companies are thus using SOX as an opportunity to restructure the way they run their business. What’s more, they’re finding they already have much of what they need—including the right people, processes, and technology.

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SciQuest Introduces New Supplier Risk Compliance Module


The latest version of SciQuest’s cloud-based spend management automation suite introduces a new Dynamic Qualification and Risk Compliance module for Total Supplier Manager (TSM) that helps customers enhance supplier management capabilities.

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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 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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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 launching the risk analysis engine, and concludes with Phase IV, which generates the report. Using the HIPPA-Watch for Security tool can help an organization comply with the Final Security Rule and help companies understand which safeguards can generate a greater return on investment.

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Privileged User Monitoring for SOX Compliance


Many companies face the Sarbanes-Oxley (SOX) compliance challenge of monitoring all the data activity of their most privileged users. Those challenges include tracking access to sensitive financial data, reporting on controls, and responding to problems. Learn about a database auditing and protection solution that can help capture targeted activities, without impacting the performance of production databases and software.

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