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 fda compliance guidance medical


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 guidance medical  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

Electronic Medical Records (EMR) for the Health Care Industry

Electronic Medical Records (EMR) assists physicians and other clinicians document patient care for current visits and provides access to patient clinical history. Sometimes may be referred to as computerized patient records (CPR). 

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Documents related to » fda compliance guidance medical

Not Yet Sold on SaaS ERP in Manufacturing? Take a Hard Look at Plex Online - Part 2


Part 1 of this blog series explained Plex Systems’ ebullience and growth despite a hostile and depressed environment, especially in the discrete manufacturing sector. While the software-as-a-service (SaaS) model is now mainstream in many functional areas of business, the article concurred with Frank Scavo’s recent assertion that, for the time being, there is only one true SaaS enterprise resource

fda compliance guidance medical  There has been no FDA guidance issued on SaaS yet. Other issues and caveats would stem from the dubious validation of software that is outside the manufacturer’s physical control in spite of the additional power and accessibility of a SaaS system. SaaS applications must be built with full redundancy, backup, and failover so that the risk of data loss is reduced to as close to zero as possible. To that end, Plex is happy to submit itself to the customer’s qualification of it as an approved vendor. Read More

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 guidance medical  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

Automotive Industry and Food, Safety, and Drug Regulations


Enterprise application providers wanting to address the distinct regulatory requirements of the automotive, food, safety, and life sciences industries need to offer enterprises industry-oriented enterprise resource planning systems that are sound and compliance-ready.

fda compliance guidance medical  Drugs, which is an FDA Compliance Policy Guide that describes how the FDA intends to enforce regulations related to labeling, electronic records, and product quality for pharmaceutical manufacturers, re-packers, re-labelers, distributors, and retailers; and US state regulations, since several states are establishing mandates that require pharmaceutical wholesalers and distributors to maintain pedigrees for every drug shipped (see Drug Pedigree Guidelines and How Software Can Help ). The enterprise 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 compliance guidance medical  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

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 guidance medical  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

Avoiding Information Overload: A Logical Approach to Managing Endpoint Security and Compliance


One of the biggest issues now facing corporations is regulatory compliance. As if corporate security threats weren’t enough, regulations such as Sarbanes-Oxley (SOX), the Gramm-Leach-Bliley Act (GLBA), and others now have long checklists of mandated requirements that must be adhered to—and thoroughly documented—by IT departments. Learn about a logical approach to managing the volumes of data required to prove compliance.

fda compliance guidance medical  Information Overload: A Logical Approach to Managing Endpoint Security and Compliance One of the biggest issues now facing corporations is regulatory compliance. As if corporate security threats weren’t enough, regulations such as Sarbanes-Oxley (SOX), the Gramm-Leach-Bliley Act (GLBA), and others now have long checklists of mandated requirements that must be adhered to—and thoroughly documented—by IT departments. Learn about a logical approach to managing the volumes of data required to 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 guidance medical  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

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 guidance medical  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

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 guidance medical  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 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.

fda compliance guidance medical  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

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 compliance guidance medical  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

Delivering Employee Compliance Training Online to Reduce Costs and Increase Productivity


Pacific Life needed to bring enterprise-wide learning technology into the company to ensure the success of compliance training. So it implemented a strategic compliance training initiative powered by SumTotal Learning Management to deliver critical online training and to streamline learning management across the enterprise. Find out the results of this initiative, including a shortened compliance training cycle by 82%.

fda compliance guidance medical  Employee Compliance Training Online to Reduce Costs and Increase Productivity Pacific Life needed to bring enterprise-wide learning technology into the company to ensure the success of compliance training. So it implemented a strategic compliance training initiative powered by SumTotal Learning Management to deliver critical online training and to streamline learning management across the enterprise. Find out the results of this initiative, including a shortened compliance training cycle by 82%. Read More

Compliance: Is Remote Office Data Your Achilles Heel?


Would spending millions of dollars and countless hours securing your data center be enough for it to pass a compliance audit? While many businesses work hard at securing their data centers, they often forget to secure remote office data. With the consequences of non-compliance ranging from financial penalties to job loss and worse, it could mean the end of your business. Don’t let compliance become your Achilles heel.

fda compliance guidance medical  Is Remote Office Data Your Achilles Heel? Would spending millions of dollars and countless hours securing your data center be enough for it to pass a compliance audit? While many businesses work hard at securing their data centers, they often forget to secure remote office data. With the consequences of non-compliance ranging from financial penalties to job loss and worse, it could mean the end of your business. Don’t let compliance become your Achilles heel. Read More

Provia Tackles RFID in a Twofold Manner Part Two: RFID Compliance


Provia's approach to radio frequency identification (RFID) compliance was to offer a bolt-on or drop-in product that works in conjunction with a company's existing logistics transactional software solution and process flows. This should put the suppliers back into control of prioritizing their IT projects because they could supposedly thereby be fairly easily and quickly made compliant with Wal-Mart or the DoD requirements for RFID. The next step for them would then be to look at how they can reap the benefits of RFID internally within their own operations.

fda compliance guidance medical  Tackles RFID in a Twofold Manner Part Two: RFID Compliance RFID Compliance These days when radio frequency identification (RFID) is constantly on everyone's lips, and when every relevant enterprise application vendor is hedging its bets towards becoming RFID-ready or is even convincing the market that its RFID-compliant solution is exactly what the doctor ( Wal-Mart , Target , Albertsons , and the US Department of Defense [ DoD ]) ordered, the typically quiet Provia Software ( www.provia.com ), a Read More