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Software Functionality Revealed in Detail
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 fda regulatory compliance certificate


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 regulatory compliance certificate  had many cases where FDA regulated companies have told it that they simply cannot use SaaS applications since they need to validate all new revisions of software in a test environment (which could take days, weeks, or months) before rolling it out to their users. Again, with most SaaS systems, the software is updated and immediately made available to all users. Even if the SaaS provider maintains the old version of the code for customers, the fact that the new system is publicly available presents

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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 regulatory compliance certificate

TEC's Mid-market ERP-Distribution Buyer’s Guide


Midsize manufacturers and distributors now have access to an array of powerful software solutions that simply weren’t available before. But with so many choices, you need accurate and unbiased information. This comprehensive guide from TEC and SupplyChainBrain provides a state-of-the-market analysis, success stories from your peers, in-depth information on solutions, and a directory of the leading vendors in the field.

fda regulatory compliance certificate  intense scrutiny by the FDA, the company faced new demands stemming from the Bioterrorism Act and the Customs Trade-Partnership Against Terrorism (CT-PAT) program as well as the enactment of the Sarbanes-Oxley Act. Many of the compliance activities were handled by manual processes with various spreadsheets, leading to insufficient controls with limited real time reporting. The company recognized the need to implement a new back office system, but the increasing demands placed on publicly-traded companies Read More

The Sunshine Act: Compliance in Expense Reporting


The Sunshine Act has prompted life science companies to look at alternatives to their expense reporting processes. The output to HHS is required to be electronic, searchable, and easily downloaded. A solution that supports these requirements from the initial input step of the process provides proactive control and management of the data—and of the direct marketing process as a whole.

fda regulatory compliance certificate  Life Sciences,Biotechnology,Pharmaceutical,Legislation,Physician Payments Sunshine Provisions,Regulatory Compliance,Sunshine Act,Expense Manangement,Expense Reporting Read More

E-discovery Compliance and The New Requirements of IT: The IT Manager’s Guide to 100% Compliance


Considering that e-mail and other electronically stored information (ESI) create the electronic equivalent of DNA evidence, there is no doubt that their evidentiary role will continue to expand. Learn how implementing a strategic e-discovery compliance program can help US and Canadian employers preserve, protect, and produce legally compliant e-mail and other ESI when compelled to do so by a court or regulatory body.

fda regulatory compliance certificate  discovery Compliance and The New Requirements of IT: The IT Manager’s Guide to 100% Compliance Considering that e-mail and other electronically stored information (ESI) create the electronic equivalent of DNA evidence, there is no doubt that their evidentiary role will continue to expand. Learn how implementing a strategic e-discovery compliance program can help US and Canadian employers preserve, protect, and produce legally compliant e-mail and other ESI when compelled to do so by a court or Read More

Paths out of the Compliance Quagmire: Plugging a Multibillion-dollar Hole


Preventable deductions are a major source of frustration and cost for suppliers, while the compliance violations that trigger them are likewise frustrating and costly for retailers. Eliminating the violations—and, thereby, eliminating the deductions—is in the best interests of both parties. Find out how a system that automates information handling processes, as well as compliance enforcement and monitoring, can help.

fda regulatory compliance certificate   Read More

Why Google Docs Must Have Compliance Management


More than 30 million users within businesses, government agencies, schools and other organizations world-wide have switched to Google Apps. Unfortunately, Google Apps does not have any built-in document compliance or records management features to meet organizational standards and legal regulations. This document discusses how to achieve regulatory and policy compliance with Google Apps.

fda regulatory compliance certificate  Google Docs Must Have Compliance Management More than 30 million users within businesses, government agencies, schools and other organizations world-wide have switched to Google Apps. Unfortunately, Google Apps does not have any built-in document compliance or records management features to meet organizational standards and legal regulations. This document discusses how to achieve regulatory and policy compliance with Google Apps. 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—implementing point solutions one after another in response to regulatory demands as they arise. This is inefficient and costly—and may result in non-compliance, due to lack of transparency. Learn how an enterprise-wide GRC approach to compliance management can help.

fda regulatory compliance certificate  Practices (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 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.

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Implementing Basel II in the Compliance Continuum


Banks can benefit enormously from understanding the various stages of the Basel II compliance program, as identified by i-flex. Banks today are discovering problems as they stumble along the path to compliance. However, if they can benchmark themselves on which stage they fall in along the continuum, and buckle themselves for the challenges that lie ahead, they will have greater success towards Basel II compliance, and enjoy the benefits of maintaining reduced capital.

fda regulatory compliance certificate   Read More

Rules, Tools, Policies, and Best Practices for Compliance in the United States


A strategic compliance program can help employers in the United States (US) reduce the likelihood of litigation, regulatory investigations, security breaches, privacy violations, and other electronic disasters. Find out what it takes to make a compliance program succeed, and learn the importance of establishing clearly written rules, formal employee education, and effective hosted-services solutions right from the start.

fda regulatory compliance certificate  Tools, Policies, and Best Practices for Compliance in the United States Compliance Rules: Rules and Tools, Policies and Best Practices for Cost-Effective, Comprehensive Compliance in the United States If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. MessageLabs, now part of Symantec, provides a range of managed services to protect, control, encrypt and archive electronic communications. Listed as a leader in the Gartner Magic 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. Key to that strategy is to adopt industry-specific enterprise software with functionality that supports Federal Drug Administration (FDA) requirements. Learn more about the criteria and recommendations you need to achieve compliance in the pharmaceutical industry.

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Enhancing Governance, Risk, and Compliance through Effective Access Risk Management


Regardless of the size of the organization, embedding governance, risk, and compliance (GRC) management into all business process is imperative. But most organizations are reactive rather than proactive when it comes to undertaking a risk management initiative. Leading companies identify building a risk-aware culture as a key strategy. Read on to find out more about ways to enable effective access risk management.

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Controlling Access Risk: Increase Visibility, Reduce the Time and Cost of Compliance


Managing end-user access to critical enterprise resources as part of an organization's IT governance, risk management, and compliance (GRC) initiative helps companies to control access risk, provide real-time visibility for multiple stakeholders, and streamline regulatory compliance. This research shows that the leading performers in controlling access risk also realize tangible financial benefits.

fda regulatory compliance certificate  Access Risk: Increase Visibility, Reduce the Time and Cost of Compliance Managing end-user access to critical enterprise resources as part of an organization's IT governance, risk management, and compliance (GRC) initiative helps companies to control access risk, provide real-time visibility for multiple stakeholders, and streamline regulatory compliance. This research shows that the leading performers in controlling access risk also realize tangible financial benefits. 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 governance while maximizing business performance. This study draws on a survey conducted by Healthcare IT News and Healthcare Finance News to share strategies that will improve governance, compliance, and business performance across today’s health care organization.

fda regulatory compliance certificate  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 governance while maximizing business performance. This study draws on a survey conducted by Healthcare IT News and Healthcare Finance News to share strategies that will improve governance, compliance, and business performance across today’s health care organization. Read More

Guide to Tax Collection Compliance: Ending the Nightmare


In mid-market report: the changing face of sales and use tax compliance, find out just how bad the problem has become, and what midsized companies ...

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