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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 manual 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 : Read More...
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 co...
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Documents related to » fda compliance manual medical


ERP Issues for the Midsized Life Sciences Company
What makes your enterprise resource planning (ERP) requirements difficult for most vendors to satisfy? As a life sciences company, you have operational

fda compliance manual medical  compliance. Compliance Strategy The FDA regulations are not a fixed target. Compliance is a key objective for any regulated company, but the requirements to meet this objective are subjective, based upon product, production processes and, perhaps most importantly, your tolerance for risk. Regulatory risk is the risk of being found out of compliance. If you accept very limited risk, your cost of compliance will be high. With more risk, compliance cost is reduced but the potential cost of non-compliance Read More...
Case Study: Align Technology, Inc.
Planning to expand, Align@a medical device manufacturer@identified electronic document management as a vital component of growth. One goal was to reduce the

fda compliance manual medical  complexities associated with the FDA's Good Manufacturing Practice (GMP) and the European ISO standard, Align needed two full-time staff members in document control to manage compliance. Given the company's forecasted growth, executives expected Align would need a total of four full-time employees within two years. It was abundantly clear to Yost that Align needed to migrate from its manual, paper-based documentation and change management processes to a comprehensive and automated document management Read More...
Supply Chain Shorts for the Week of December 13, 2013
Bob Eastman, senior SCM analyst, brings you a round-up of news from Syspro, American Software, and SERUS.

fda compliance manual medical  greater pressures from the FDA, hyper competition, tighter shipping expectations, heightening customer quality expectations, rising commodity prices, and a continuing squeeze on margins.(Scott was talking about this the same day that NBC News was reporting the recall of some 90,000 pounds of meat by Yauk's Specialty Meats of Windsor, CO, that was produced under some not-so-sanitary conditions.) SYSPRO is, of course, not the only player in this space. But when you listen to SYSPRO’s market focus, and 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

fda compliance manual medical  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...
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 manual medical  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...
Data Storage Encryption for Enabling PCI Compliance
Compliance with the Payment Card Industry Data Security Standard (PCI DSS) is mandatory. As such, businesses must think seriously about their data storage

fda compliance manual medical  Storage Encryption for Enabling PCI Compliance Compliance with the Payment Card Industry Data Security Standard (PCI DSS) is mandatory. As such, businesses must think seriously about their data storage security and the day-to-day encryption management of their customer data. As a merchant or credit card processor, will you be ready when the auditors come knocking? Learn more about the foolproof way that many businesses are passing PCI DSS audits. 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 manual medical  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...
Winning the PCI Compliance Battle
The payment card industry (PCI) Data Security Standard establishes common processes and precautions for handling credit card data. Although achieving PCI

fda compliance manual medical  the PCI Compliance Battle Winning the PCI Compliance Battle If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. Qualys® is headquartered in Redwood Shores, California, with offices in France, Germany, the U.K., Japan and Hong Kong, and has partners worldwide. Source : Qualys Resources Related to Payment Card Industry (PCI) : Payment Card Industry (PCI) (Wikipedia) Winning the PCI Compliance Battle PCI Compliance is also known as : 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 manual medical  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...
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

fda compliance manual medical  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...
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

fda compliance manual medical  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 Read More...
Managing Compliance with 21 CFR Part 11
Compliance with regulatory requirements is a business-critical need you must maintain. But meeting this need is more challenging with the creation of new

fda compliance manual medical  Compliance with 21 CFR Part 11 Compliance with regulatory requirements is a business-critical need you must maintain. But meeting this need is more challenging with the creation of new regulations, such as 21 CFR Part 11, governing the use of software for secure data processing. But compliance is possible: an enterprise resource planning (ERP) system can help with audits, document and digital signatures, validation scripts, and other security needs. Read More...
Retailer-centric Planning: Compliance to Collaboration
In a game where the goals don’t change, but the rules do, winners and losers are determined by how well each team sees the big picture. Thus, suppliers who

fda compliance manual medical  centric Planning: Compliance to Collaboration In a game where the goals don’t change, but the rules do, winners and losers are determined by how well each team sees the big picture. Thus, suppliers who understand and support retailers’ goals have a better likelihood of success. The greater the alignment of processes and communication between suppliers and retailers, the greater the chances of a big win. Read More...

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