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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 programs  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 : Read More...
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 requirement...
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Documents related to » fda compliance programs


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

fda compliance programs  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...
Fighting Terrorism with Global Trade Management
The challenge for government and industry is to secure trade without impeding growth. Therefore, there is a greater need for timely information updated by

fda compliance programs  to be made to FDA within four hours; and prior notice of food import shipments before allowed entry to the US Patriot Act of 2002 This Act, signed into law by the US president, requires that financial institutions know their customers and, to the greatest extent possible, their customers' customers. (Source: TradeBeam ) One should notice a multitude of complex interactions between the global trade flows within a secure supply chain. Namely, across few dozens of required pertinent processes, global trade Read More...
The Many Faces of PLM Part Two: The Future of the PLM Suite
The future of the PLM Suite will include more applications that cover product-related functionality and further expand the benefits available. As the PLM Suite

fda compliance programs  their capabilities to support FDA 21 CFR Part 11, an important requirement in the Life Sciences industry. This focus is increasingly important as new regulations are being unfurled, such as WEEE (Waste Electronic and Electrical Equipment) and the TREAD (Transportation Recall Enhancement, Accountability, and Documentation), whose requirements span large segments of the product lifecycle. PLM focus on regulatory and compliance issues is not entirely new, as SAP has long included Environmental Health and Read More...
Has Consolidation Made the PLM Market More Agile?
While the race for the pole position in the still evolving, moving-target PLM market started several years ago, it has been quite accelerated by Agile Software

fda compliance programs  compliance, such as satisfying FDA requirements for closed-loop, corrective action/preventative action (CAPA) management and Compliance with FDA Title 21 CFR Part 11, which prescribes the accepted use of electronic records and signatures. The agileMD solution entails: Agile's PLM solution for managing the medical device product record from research and development, clinical trials, regulatory approval, new product introduction (NPI), market acceptance, to product phase-out. Medical device best practices Read More...
Aligning Financials for Improved Business Value and Compliance
In Align Financial Processes and Systems for Better Business Value and Compliance, learn how an integrated, life-cycle approach to financial manage...

fda compliance programs  Financials for Improved Business Value and Compliance If your company uses disparate software systems, spreadsheets, and manual workarounds to drive financial outcomes, you may be stifling your business. In Align Financial Processes and Systems for Better Business Value and Compliance , learn how an integrated, life-cycle approach to financial management can dramatically improve your financial analysis, performance, and reporting. You'll discover how the right financial approach can help you gain Read More...
Customer Compliance Demands: Beast of Burden, or New Business Opportunity
Today, compliance pains come from three sources: government, large industrial or retail customers, and even smaller customers who are asking for unique delivery

fda compliance programs  Compliance Demands: Beast of Burden, or New Business Opportunity Today, compliance pains come from three sources: government, large industrial or retail customers, and even smaller customers who are asking for unique delivery, packaging, assembly or other services. This white paper presents compliance as an enormous opportunity for the small to medium size business owner. Read it and understand the compliance demands within the distribution environment and how they affect your business. 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

fda compliance programs  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...
Leverage Your Financial System to Enable Sarbanes-Oxley Compliance: An Evaluator’s Guide
When it comes to US Sarbanes-Oxley Act (SOX) compliance, the role of financial information systems simply cannot be overlooked. This was recently underscored by

fda compliance programs   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

fda compliance programs  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...
Proactive IT Triage for Sarbanes-Oxley Compliance
When it comes to Sarbanes-Oxley compliance, most IT organizations do not lack measurement data—in fact, they’re buried in it! What they need are effective ways

fda compliance programs  IT Triage for Sarbanes-Oxley Compliance When it comes to Sarbanes-Oxley compliance, most IT organizations do not lack measurement data—in fact, they’re buried in it! What they need are effective ways to put these measurements into the context of critical business services, establish baselines for every layer of every component, and proactively communicate which layer of which component is the root cause of any abnormality. Read More...
Cigna Finds Good Therapy: Building a More Efficient Risk Management, Compliance, and System Security Program
As a provider of employee benefits, CIGNA must observe a bevy of regulatory compliance mandates. Because much of its efforts are compliance-focused, it

fda compliance programs  Finds Good Therapy: Building a More Efficient Risk Management, Compliance, and System Security Program As a provider of employee benefits, CIGNA must observe a bevy of regulatory compliance mandates. Because much of its efforts are compliance-focused, it continually embraces technology, searching for new products to better manage its benefit offerings and track its security risks. With QualysGuard’s vulnerability management solution, CIGNA has mitigated vulnerabilities and remained up-to-date with 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

fda compliance programs  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...
One Vendor's Dedicated Governance, Risk Management, and Compliance Unit
SAP's governance, risk management, and compliance roadmap is still in its beginning stages. Only time will prove the vendor's delivery of true, tangible

fda compliance programs  Food and Drug Administration (FDA) compliance tools, with Oracle, Microsoft , Lawson , Infor , LogicalApps , Oversight Systems , and CODA being only some of the more notable ones. Still, SAP's concerted effort deserves kudos, since even now the vendor offers a GRC solution set that covers a range of regulations in such areas as anti-terrorism, anti-money laundering, Basel II, Solvency II, data privacy, SOX compliance, and beyond, as opposed to most competitors' sporadic GRC nuggets. Most notably, SAP has 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

fda compliance programs  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...
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