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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  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 manual


The Challenges of Defining and Managing Governance, Risk Management, and Compliance
A broader, more structured approach is needed to effectively manage governance, risk management, and compliance (GRC). Enterprises will then be better able to

fda compliance manual  recommended. For instance, the FDA regulations for drug manufacturers are not fixed targets. Thus, compliance is a key objective for any regulated drug manufacturing company, but the requirements to meet compliance are subjective based upon product, production processes, and (perhaps most important) every company's tolerance for risk. Regulatory risk is the risk of being found out of compliance, and if a company accepts very limited risk, its cost of compliance will logically be high. Conversely, with 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  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...
Process-based Governance, Risk Management, and Compliance
The right balance of automated processes with paper records and manual, human interaction is necessary to keep costs under control with a flexible yet

fda compliance manual  paper by Olin Thompson, FDA Compliance for the Life Sciences ). In any organization, evaluation of the characteristics of operations, products, and so forth will reveal the mix of standard versus exceptional circumstances. The most effective procedures will allow computer systems to assist in repetitive operations. At the same time, computers can integrate manual or semi-manual approaches to exceptions, which should be captured in a digital form to facilitate the storing and retrieving of documents, 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  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...
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  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...
Compliance and Traceability in Manufacturing
Manufacturers focus on compliance and traceability initiatives for a variety of reasons, including compliance to regulatory mandates and mitigating risk of

fda compliance manual  and Traceability in Manufacturing Manufacturers focus on compliance and traceability initiatives for a variety of reasons, including compliance to regulatory mandates and mitigating risk of product recalls. Companies are increasingly focused on reducing manufacturing costs and particularly the cost of poor quality with end-to-end traceability of product and processes. Read here to know the key capabilities that help compliance and traceability initiatives. Read More...
Getting a Return on Supply Chain Compliance
Change your paradigm by using supply chain compliance as a competitive tool to grow your business.  By viewing your organization from the inside out, you’ll

fda compliance manual  a Return on Supply Chain Compliance Change your paradigm by using supply chain compliance as a competitive tool to grow your business.  By viewing your organization from the inside out, you’ll make better decisions and better position your company against the competition by building strategic partnerships. 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  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...
A Consolidated Archive Storage Array for Compliance and Retention
Reliance on enterprise data is growing at exponential rates. And thanks to internal processes and legal requirements, the period of time that data must be

fda compliance manual  Consolidated Archive Storage Array for Compliance and Retention Reliance on enterprise data is growing at exponential rates. And thanks to internal processes and legal requirements, the period of time that data must be retained is increasing—as is the cost of retaining the data itself. As storage needs grow, the cost of deploying siloed storage systems is becoming unmanageable. Find out how consolidating resources can translate into bottom-line savings for your enterprise. Read More...
Compliance: A Work in Progress
There’s no magic bullet for compliance success@even the most experienced organizations use a combination of reliable processes and proven technologies to get

fda compliance manual  A Work in Progress There’s no magic bullet for compliance success—even the most experienced organizations use a combination of reliable processes and proven technologies to get the job done. But identifying, designing, and executing the right internal controls to meet compliance standards in a large, global company can be arduous and expensive. The systems you use to support compliance efforts must be implemented well. Find out more. 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 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...
Increasing Business Agility: An Integrated Approach to Governance, Risk, and Compliance Management
A benchmarking survey shows that most organizations have a reactive method to governance, risk, and compliance (GRC) management, channeling resources and

fda compliance manual  Business Agility: An Integrated Approach to Governance, Risk, and Compliance Management A benchmarking survey shows that most organizations have a reactive method to governance, risk, and compliance (GRC) management, channeling resources and management attention to address specific regulatory mandates independently and in isolation from each other. The result: fragmented GRC activities and data sources that increase costs and hinder business agility. Find out how your company can become less reac 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 manual   Read More...
LogRhythm and SOX Compliance
In order for a business to stay on top of compliance requirements required by the Sarbanes-Oxley Act (SOX)—and avoid financial penalties or possible jail time

fda compliance manual  and SOX Compliance In order for a business to stay on top of compliance requirements required by the Sarbanes-Oxley Act (SOX)—and avoid financial penalties or possible jail time—it must take a good look at its IT environment and financial reporting processes. The collection, management, and analysis of log data are integral to meeting SOX requirements and as such, require a system that automates these processes across the IT infrastructure. Read More...

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