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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
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
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

fda compliance manual 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
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
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
Export Operations & Compliance Benchmark Report: Going Global with Regulatory Reform
This second annual benchmark study covers U.S. export operations and compliance. The survey covered export regulatory reform, operations management practices

fda compliance manual medical  Operations & Compliance Benchmark Report: Going Global with Regulatory Reform This second annual benchmark study covers U.S. export operations and compliance. The survey covered export regulatory reform, operations management practices, organizational structure, compliance policies, and export management technology. This year’s study looks at the impact of going global with export control reform. Read More
Privileged User Monitoring for SOX Compliance
Many companies face the Sarbanes-Oxley (SOX) compliance challenge of monitoring all the data activity of their most privileged users. Those challenges include

fda compliance manual medical  User Monitoring for SOX Compliance Many companies face the Sarbanes-Oxley (SOX) compliance challenge of monitoring all the data activity of their most privileged users. Those challenges include tracking access to sensitive financial data, reporting on controls, and responding to problems. Learn about a database auditing and protection solution that can help capture targeted activities, without impacting the performance of production databases and software. Read More
The Value of a Learning Management Compliance Solution
Companies spend millions each year conducting mandatory training. Whether triggered by an audit, the risk of non-compliance, bad PR, or internal training

fda compliance manual medical  Value of a Learning Management Compliance Solution Companies spend millions each year conducting mandatory training. Whether triggered by an audit, the risk of non-compliance, bad PR, or internal training requirements, achieving compliance can be difficult and costly. One of the biggest challenges that organizations face today is reducing costs from fines and lawsuits. Download this white paper to find out how a learning management compliance solution can help manage your compliance requirements. Read More
Top 5 HR Compliance Concerns for Small Business
Small and medium-sized companies can be so focused on core business issues that they overlook one of their most potentially serious and costly issues—human

fda compliance manual medical  5 HR Compliance Concerns for Small Business Small and medium-sized companies can be so focused on core business issues that they overlook one of their most potentially serious and costly issues—human resource compliance. They often lack the time and resources to build infrastructure and processes that are beyond core business objectives. This paper discusses the top small business compliance concerns. 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 manual 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
Are You on Track for 21 CFR Part 203 Compliance?
It’s old, it’s new, and it’s the future. Pedigree tracking regulations were originally passed into law through the Prescription Drug Marketing Act of 1987 (PDMA

fda compliance manual medical  Food and Drug Administration (FDA) has lifted its final stay. Pharmaceutical companies are expected to be in compliance with 21 CFR Part 203 by the year 2011. Do you have what it takes for compliance? 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 manual medical  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
Electronic Medical Records: An Introduction
Electronic medical records (EMR) serves a niche market. This software caters specifically to health care professionals working in clinics, private practices

fda compliance manual medical  electronic medical records,EMR,EMR systems,paper health records,health care industry,health care organizations,health care system,patient data,medical history,medication list,family history,Institute of Medicine,compliance,voice recognition system,Health Insurance Portability and Accountability Act Read More
SciQuest Introduces New Supplier Risk Compliance Module
The latest version of SciQuest’s cloud-based spend management automation suite introduces a new Dynamic Qualification and Risk Compliance module for Total

fda compliance manual medical  Introduces New Supplier Risk Compliance Module The latest version of SciQuest ’s cloud-based spend management automation suite introduces a new Dynamic Qualification and Risk Compliance module for Total Supplier Manager (TSM) that helps customers enhance supplier management capabilities. This new module allows for a more thorough supplier vetting process, enabling customers to further qualify suppliers by collecting risk-based information and assess vendor status or compliance. Other new Read More

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