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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 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 : 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 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...
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

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...
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

fda compliance program guidance manual  Food Safety Information | FDA Food Safety | Food Safety Articles | Hazard Analysis and Critical Control Point | Food Control Jurisdictions | Ensuring Food Safety | HACCP Concept | Food Safety Manager | Food Safety Hygiene | Food Health Safety | Food Safety Research | Food Safety and Inspection Service | Food Safety Consultant | HACCP Plan | Food Safety Issues | Food Safety Resources | Food Safety Authority | Food Safety Solutions | Food Safety Program | Proactive Food Safety Strategy | Food and Drug Read More...
Avoiding Costly Fines: A 2011 Guide to Compliance Mandates
It’s up to human resources (HR) to ensure that hiring, discipline, and termination practices are compliant with the law. Otherwise, you could put your company

fda compliance program guidance manual  Costly Fines: A 2011 Guide to Compliance Mandates It’s up to human resources (HR) to ensure that hiring, discipline, and termination practices are compliant with the law. Otherwise, you could put your company at risk of incurring fines, penalties, and employee lawsuits. Find out all about the latest workforce compliance and safety laws and regulations that may affect your organization so you can train management and employees, and avoid expensive employee lawsuits. Read More...
Governance, Regulation and Compliance
Companies must meet GRC criteria defined by internal and external policies, as failing to do so can have business and legal consequences. Although management of

fda compliance program guidance manual  Regulation and Compliance Companies must meet GRC criteria defined by internal and external policies, as failing to do so can have business and legal consequences. Although management of travel and entertainment (T&E) expenses is often seen as being of low importance for overall GRC, poorly managed T&E can lead to unforeseen issues with long-term business impact. See why using an external T&E management provider is the best way to adhere to GRC. Read More...
Sarbanes-Oxley Database Compliance
Under the US Sarbanes-Oxley Act, companies must maintain proven auditing practices and assure integrity and timeliness of data. Thus, companies must secure

fda compliance program guidance manual  Oxley Database Compliance Under the US Sarbanes-Oxley Act, companies must maintain proven auditing practices and assure integrity and timeliness of data. Thus, companies must secure systems that monitor corporate data. To effectively accomplish this, you are best off investing in a solution that can comprehensively cover your reporting and auditing needs while providing you the capacity to respond swiftly should any incidents occur. Read More...
Computer Guidance Corp’s Construction ERP Longevity
I have only recently been made aware of Computer Guidance Corporation (CGC) and its leading construction ERP solution for architecture, engineering, and

fda compliance program guidance manual  CGC, Computer Guidance Corporation, construction, architecture, engineering, construction ERP, eCMS Read More...
Mitigating Compliance Risk from Third Party Intermediaries
Compliance officers need steady nerves to manage the legal and compliance risks posed by third-party intermediaries. Regardless of how well respected the third

fda compliance program guidance manual  Compliance Risk from Third Party Intermediaries Compliance officers need steady nerves to manage the legal and compliance risks posed by third-party intermediaries. Regardless of how well respected the third-party organization, how well written the contract, or how well established the brand company’s in-house compliance program, compliance requires effective third-party risk management. Read this paper and know the 5 critical steps in managing third-party compliance risk. Read More...
Meet PCI DSS Compliance Requirements for Test Data with Data Masking
Whether you’re working toward your first or your next payment card industry (PCI) data security standard (DSS) audit, you know compliance is measured on a

fda compliance program guidance manual  PCI DSS Compliance Requirements for Test Data with Data Masking Whether you’re working toward your first or your next payment card industry (PCI) data security standard (DSS) audit, you know compliance is measured on a sliding scale. But full compliance can’t be achieved with just one policy or technology. Using data masking, a technology that alters sensitive information while preserving realism, production data can be eliminated from testing and development environments. Learn more. Read More...
Avoiding the Compliance Trap for Travel and Expenses
Maximizing transparency and control over travel and expense (T&E) management is essential in a compliant-conscious market. Purpose-built software and on-demand

fda compliance program guidance manual  the Compliance Trap for Travel and Expenses Maximizing transparency and control over travel and expense (T&E) management is essential in a compliant-conscious market. Purpose-built software and on-demand services are part of a best-practices approach that help with not only streamlining your processes, but also analysis and reporting. Find out what you need to know about automated T&E solutions—and how they can help you reduce your risk of noncompliance. Read More...
Improving Regulatory Compliance with Encryption
As a bedrock element of any sound corporate data protection strategy, encryption protects valuable company data, whether it is at rest, in transit, or in use

fda compliance program guidance manual  Regulatory Compliance with Encryption As a bedrock element of any sound corporate data protection strategy, encryption protects valuable company data, whether it is at rest, in transit, or in use. Advanced encryption algorithms coupled with faster processors now make it possible to transparently encrypt and decrypt entire drive volumes, massive amounts of data on storage area networks (SANs), and other large-volume data stores. 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

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...
Compliance and Privileged Password Management
Today’s increasing compliance requirements have focused additional attention on how enterprises manage and control these critical accounts and passwords. How

fda compliance program guidance manual  and Privileged Password Management Today’s increasing compliance requirements have focused additional attention on how enterprises manage and control these critical accounts and passwords. How can you address the requirement for shared privileged access while still maximizing information security? Find out how traditional solutions may not be providing the security you need—and how upgrading your password system with an automated solution can help. Read More...

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