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Software Functionality Revealed in Detail
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 fda compliance 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 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.

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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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Documents related to » fda compliance manual

The Challenges of Defining and Managing Governance, Risk Management, and Compliance


A broader, more structured approach is needed to effectively manage governance, risk management, and compliance (GRC). Enterprises will then be better able to guide their people, standardize their processes, and unify technology to embed GRC at all organizational levels.

fda compliance manual  recommended. For instance, the FDA regulations for drug manufacturers are not fixed targets. Thus, compliance is a key objective for any regulated drug manufacturing company, but the requirements to meet compliance are subjective based upon product, production processes, and (perhaps most important) every company's tolerance for risk. Regulatory risk is the risk of being found out of compliance, and if a company accepts very limited risk, its cost of compliance will logically be high. Conversely, with Read More

Global Trade and the Role of Governance, Risk Management, and Compliance Software


The growing number of legal and regulatory requirements associated with global trading is one of many reasons enterprises are looking into global trade management applications, and into harnessing the up-and-coming, strategic software category of governance, risk management, and compliance.

fda compliance manual  incarceration of executives (see FDA Compliance For The Life Sciences ). As another example, implementing and ensuring compliance with employee safety guidelines, monitoring emissions (which are often delineated by regulatory permits), and even validating the origin and composition of chemical products are all mission-critical processes that contribute to the cost of doing business. In other words, as explained in So, What's the Big Deal with Chemicals? , a new complexity that comes from some process 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 assisting companies to meet the increasing challenges of corporate compliance and risk management.

fda compliance manual  Food and Drug Administration (FDA) requirements for pharmaceutical companies; and Basel II for the banking sector. This is part one of the two-part article How a Leading Vendor Embraces Governance, Risk Management, and Compliance . In part two, SAP's GRC product suite will be discussed in more detail, and speculation will be made on the product suite's potential for success within the vendor's current and prospective customer base. 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.

fda compliance manual  Compliance Mistakes | Deacom FDA Compliance | Deacom Compliance Plan | Deacom Inc Compliance Issues | Deacom Approach to Compliance | Deacom Achieving Compliance | Deacom Compliance Demands | Deacom Compliance Objectives | Deacom Compliance Regulations | Level of Compliance Deacom Inc | Deacom Inc FDA Compliance Needs | Deacom GMP Compliance | Deacom Reaching Compliance | Compliance Strategy Deacom | Compliance Strategies Deacom | Strategies for Compliance Deacom | Strategies for Overcoming Compliancy Read More

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 compliance manual  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

Providing a Foundation for Regulatory Compliance


Regulations regarding digital information use, storage, and protection are meant to help maintain the integrity and security of public and private networks. Compliance measures such as the payment card industry (PCI), the Gramm-Leach-Bliley Act (GLBA), and others focus on the long-term retention and integrity of all data. Achieving secure, long-term data retention is easier with log management and incident response tools.

fda compliance manual  a Foundation for Regulatory Compliance Regulations regarding digital information use, storage, and protection are meant to help maintain the integrity and security of public and private networks. Compliance measures such as the payment card industry (PCI), the Gramm-Leach-Bliley Act (GLBA), and others focus on the long-term retention and integrity of all data. Achieving secure, long-term data retention is easier with log management and incident response tools. Read More

Compliance and Traceability in Manufacturing


Manufacturers focus on compliance and traceability initiatives for a variety of reasons, including compliance to regulatory mandates and mitigating risk of product recalls. Companies are increasingly focused on reducing manufacturing costs and particularly the cost of poor quality with end-to-end traceability of product and processes. Read here to know the key capabilities that help compliance and traceability initiatives.

fda compliance manual  and Traceability in Manufacturing Manufacturers focus on compliance and traceability initiatives for a variety of reasons, including compliance to regulatory mandates and mitigating risk of product recalls. Companies are increasingly focused on reducing manufacturing costs and particularly the cost of poor quality with end-to-end traceability of product and processes. Read here to know the key capabilities that help compliance and traceability initiatives. Read More

Compliance, Not Conflict: From IT Security vs. IT Operations,


It’s an inescapable, undisputable fact that most organizations have conflict between IT security and IT operations. Having been given two distinctive—yet potentially contradictory—goals, in a sense they were destined to be at odds with one another. What does it take to bridge the gap between these two teams to achieve compliance? Can standardized processes and software tools help (or hinder) this effort? Find out here.

fda compliance manual   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 compliance manual  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

A Quality and Compliance Training Road Map for Emerging FDA-regulated Companies


A Quality and Compliance Training Road Map for Emerging FDA-Regulated Companies Emerging life science companies face the same compliance and regulatory pressures as larger ones. Companies that outsource sales and operational functions need to disseminate training on key policies, procedures, and regulations to a wide audience—without the benefit of a dedicated training team. These companies demand solutions that automate the quality training effort without compromising the entire quality program.

fda compliance manual  Road Map for Emerging FDA-regulated Companies A Quality and Compliance Training Road Map for Emerging FDA-Regulated Companies Emerging life science companies face the same compliance and regulatory pressures as larger ones. Companies that outsource sales and operational functions need to disseminate training on key policies, procedures, and regulations to a wide audience—without the benefit of a dedicated training team. These companies demand solutions that automate the quality training effort without Read More

Governance & Compliance: Rise above the Crisis of Trust


What you need is a coherent, integrated approach to grc, as you'll discover in the white paper trust and competitive advantage: an integrated appro...

fda compliance manual  & Compliance: Rise above the Crisis of Trust In the post-Enron world, an ad hoc approach to governance, risk management, and compliance (GRC) just won't cut it. Not with customers, shareholders, regulators, or suppliers . You stand to lose in so many ways—lost business, fines, public embarrassment, and increased overhead. What you need is a coherent, integrated approach to GRC , as you'll discover in the white paper Trust and Competitive Advantage: An Integrated Approach . Learn how an Read More

The Age of Compliance: Preparing for a Riskier and More Regulated World


The three themes of governance, risk, and compliance (GRC) have been central to the management agenda for a decade. But whereas years ago it was the “C” in GRC that kept executives awake at night (and indeed was the impetus behind the development of GRC in the first place), in the post-crisis world it is the “R” that has risen to the top of the agenda. Learn about a more efficient approach to managing risk and compliance.

fda compliance manual  Age of Compliance: Preparing for a Riskier and More Regulated World The three themes of governance, risk, and compliance (GRC) have been central to the management agenda for a decade. But whereas years ago it was the “C” in GRC that kept executives awake at night (and indeed was the impetus behind the development of GRC in the first place), in the post-crisis world it is the “R” that has risen to the top of the agenda. Learn about a more efficient approach to managing risk and compliance. BEGI Read More

ERP Selection Series: Requirements for an FDA-regulated Environment


The FDA imposes strict process controls on food and pharmaceutical manufacturers for good reason. Consequences of mistakes are hefty—ranging from costly recalls and lawsuits to illness and death. Food and pharmaceutical manufacturers need to keep profitability high while maintaining strict quality-control standards. See how your ERP software can make the difference between process control and business-crippling process instability.

fda compliance manual  an FDA-regulated Environment The FDA imposes strict process controls on food and pharmaceutical manufacturers for good reason. Consequences of mistakes are hefty—ranging from costly recalls and lawsuits to illness and death. Food and pharmaceutical manufacturers need to keep profitability high while maintaining strict quality-control standards. See how your ERP software can make the difference between process control and business-crippling process instability. Read More

LogRhythm and SOX Compliance


In order for a business to stay on top of compliance requirements required by the Sarbanes-Oxley Act (SOX)—and avoid financial penalties or possible jail time—it must take a good look at its IT environment and financial reporting processes. The collection, management, and analysis of log data are integral to meeting SOX requirements and as such, require a system that automates these processes across the IT infrastructure.

fda compliance manual  and SOX Compliance In order for a business to stay on top of compliance requirements required by the Sarbanes-Oxley Act (SOX)—and avoid financial penalties or possible jail time—it must take a good look at its IT environment and financial reporting processes. The collection, management, and analysis of log data are integral to meeting SOX requirements and as such, require a system that automates these processes across the IT infrastructure. Read More