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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

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

fda compliance program guidance manual  the defense industry, while FDA compliance requirements are causing medical manufacturers to shy away from hosted solutions. Namely, these regulations call for adherence to specific processes and data sets when using automated or electronic systems. They also have an impact on how customers need to test and validate the software they use to help build their products. Unfortunately, these validation processes add yet another layer of complexity to SaaS systems since customers will need to go through a Read More

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.

fda compliance program guidance manual  (WEEE) directive, and U.S. FDA requirements imposing important accountability and visibility mandates. Depicting the flow of documents through supply chain processes is not enough to provide the visibility that companies really need. To properly close the loop, document flow must be combined with quality indicators, such as timely execution and confirmation data, and expected versus actual values of such variables as product quantity. Data on process duration and the personnel involved should also be 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 International Traffic in Arms Regulations (ITAR). To answer this challenge, you need a solution that automates core ITAR processes—a solution that stores all your licenses and related documents where you can keep tabs on them.

fda compliance program guidance manual  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 International Traffic in Arms Regulations (ITAR). To answer this challenge, you need a solution that automates core ITAR processes—a solution that stores all your licenses and related documents where you can keep tabs on them. Read More

Achieving PCI Compliance for Privileged Password Management and Remote Vendor Access


Noncompliance with Payment Card Industry (PCI) standards can have a devastating effect on any company that relies on credit card transactions. Contractual penalties and revocation of your rights to process credit card transactions are just two potential repercussions. Though there is no single solution for PCI compliance, you can minimize the risks by staying on top of the latest products and procedures. Learn more.

fda compliance program guidance manual  PCI Compliance for Privileged Password Management and Remote Vendor Access Noncompliance with Payment Card Industry (PCI) standards can have a devastating effect on any company that relies on credit card transactions. Contractual penalties and revocation of your rights to process credit card transactions are just two potential repercussions. Though there is no single solution for PCI compliance, you can minimize the risks by staying on top of the latest products and procedures. Learn more. Read More

Tracking Limitations to Business Policies: Using Compliance-based Solutions as an Opportunity


Risk managers and compliance officials in banking institutions often face problems of how to measure and monitor risk and incorporate risk practices. Solutions to these problems must be linked to decision-making processes, but they also need to increase the speed at which institutions can react to market changes. Can new risk management solutions really deliver compliance in a verifiable, measurable, and timely manner?

fda compliance program guidance manual  Limitations to Business Policies: Using Compliance-based Solutions as an Opportunity Risk managers and compliance officials in banking institutions often face problems of how to measure and monitor risk and incorporate risk practices. Solutions to these problems must be linked to decision-making processes, but they also need to increase the speed at which institutions can react to market changes. Can new risk management solutions really deliver compliance in a verifiable, measurable, and timely Read More

Top 5 HR Compliance Concerns for Small Business


Small and medium-sized companies can be so focused on core business issues that they overlook one of their most potentially serious and costly issues—human resource compliance. They often lack the time and resources to build infrastructure and processes that are beyond core business objectives. This paper discusses the top small business compliance concerns. 

fda compliance program guidance manual  5 HR Compliance Concerns for Small Business Small and medium-sized companies can be so focused on core business issues that they overlook one of their most potentially serious and costly issues—human resource compliance. They often lack the time and resources to build infrastructure and processes that are beyond core business objectives. This paper discusses the top small business compliance concerns. Read More

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 are distinct, they’re also synergistic—in fact, PCI recommends using data auditing as a substitute for encryption. Learn more about an auditing and encryption solution that can help you make better decisions about protecting your and your clients’ sensitive data.

fda compliance program guidance manual  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 are distinct, they’re also synergistic—in fact, PCI recommends using data auditing as a substitute for encryption. Learn more about an auditing and encryption solution that can help you make better decisions about protecting your and your clients’ sensitive data. Read More

Enterprise Search for E-discovery Compliance


Enterprise search is rapidly emerging as a key component to electronic discovery, and is proving to be the very technology that organizations need to comply with US Federal Rules of Civil Procedure (FRCP). But not all enterprise search software is the same, and conducting a review of the various technologies available can be a daunting task. Find out what you’ll need to look for to ensure regulatory compliance.

fda compliance program guidance manual  Search for E-discovery Compliance Enterprise search is rapidly emerging as a key component to electronic discovery, and is proving to be the very technology that organizations need to comply with US Federal Rules of Civil Procedure (FRCP). But not all enterprise search software is the same, and conducting a review of the various technologies available can be a daunting task. Find out what you’ll need to look for to ensure regulatory compliance. Read More

Enhanced Courseware for Compliance and Risk Mitigation Training from Skillsoft


Skillsoft announced that it has added new content courses to its compliance and risk mitigation courseware collection. Skillsoft's compliance courses—available on demand—are aimed at preparing individuals for exams and meeting regulatory requirements. The courses have been compiled in collaboration with subject matter experts and cover organization-specific legal requirements as well

fda compliance program guidance manual  Courseware for Compliance and Risk Mitigation Training from Skillsoft Skillsoft announced that it  has added new content courses  to its compliance and risk mitigation courseware collection. Skillsoft's compliance courses—available on demand—are aimed at preparing individuals for exams and meeting regulatory requirements. The courses have been compiled in collaboration with subject matter experts and cover organization-specific legal requirements as well as ethics, bribery, harassment, Read More

Enhancing Governance, Risk, and Compliance through Effective Risk Management


Embedding governance, risk, and compliance (GRC) management into all business process has become imperative. Companies need to adopt a holistic view when it comes to reducing and managing risks, and ensure better access risk management. This paper discusses the need for companies to take a proactive approach towards access risk management.

fda compliance program guidance manual  Governance, Risk, and Compliance through Effective Risk Management Embedding governance, risk, and compliance (GRC) management into all business process has become imperative. Companies need to adopt a holistic view when it comes to reducing and managing risks, and ensure better access risk management. This paper discusses the need for companies to take a proactive approach towards access risk management. Read More

The Convergence of Enterprise Governance, Risk & Compliance Software Solutions


The market for governance, risk, and compliance is still a maelstrom. Some vendors offer GRC software for the enterprise (eGRC), whereas others offer GRC for monitoring access and communications for compliance (IT-GRC). What’s more—both branches of GRC use technology to automate highly complex processes, while some GRC vendors offer capabilities that overlap both areas. To get a sense of the current attitudes toward GRC, Hypatia Research evaluated more than 20 GRC software vendors and interviewed more than 660 users of these applications. Read up on best practices, benchmarks, and vendor ranking.

fda compliance program guidance manual  Convergence of Enterprise Governance, Risk & Compliance Software Solutions The market for governance, risk, and compliance is still a maelstrom. Some vendors offer GRC software for the enterprise (eGRC), whereas others offer GRC for monitoring access and communications for compliance (IT-GRC). What’s more—both branches of GRC use technology to automate highly complex processes, while some GRC vendors offer capabilities that overlap both areas. To get a sense of the current attitudes toward GRC, Read More

Achieving Efficient Governance, Risk, and Compliance (GRC) through Process and Automation


Newly available software platforms known as governance, risk, and compliance (GRC) technologies can help your business stay on top of the myriad procedures, tasks, and behaviors that bear upon compliance. This paper discusses the drivers behind the growing awareness of GRC information technology, introduces the elements of an effective automated GRC system, and suggests a low-risk, high-impact approach to launching GRC automation.

fda compliance program guidance manual  Efficient Governance, Risk, and Compliance (GRC) through Process and Automation Newly available software platforms known as governance, risk, and compliance (GRC) technologies can help your business stay on top of the myriad procedures, tasks, and behaviors that bear upon compliance. This paper discusses the drivers behind the growing awareness of GRC information technology, introduces the elements of an effective automated GRC system, and suggests a low-risk, high-impact approach to launching Read More