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Software Functionality Revealed in Detail
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 gmp regulatory


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

gmp regulatory  specifies legal requirements for GMP in the EU, and it requires that data be available at the proper time, provided in a readable form, and protected against damage or loss. ICH Q7A Guideline— International Conference on Harmonization (ICH) Q7A provides guidelines for active pharmaceutical ingredients in the EU, the US, and Japan. PIC/S—The Pharmaceutical Inspection Cooperation Scheme (PIC/S) and the Pharmaceutical Inspection Convention provide guidance on pharmaceutical inspections. Well-attuned

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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

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 requirements needs, as well as product related components of environmental health and safety (EH&S). 

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Documents related to » gmp regulatory

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 processes that set you apart from other manufacturing companies. And, your regulatory requirements, including 21 CFR part 11, aren’t like those of any other industry. The challenge is to manage compliance risks and compliance costs. Learn about an ERP compliance strategy.

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Orchid Orthopedic Solutions Selects CEBOS QMS


Orchid Orthopedic Solutions recently selected CEBOS MQ1 Elements Life Sciences solution to automate its quality management system (QMS) and ensure compliance with industry-specific quality standards. Orchid is a worldwide provider of contract design and manufacturing for the orthopedic and medical device markets.

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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 have long embraced enterprise resource planning (ERP) and customer relationship management (CRM), but primarily use them to achieve operational efficiencies. However these systems can play a significant role in their abilities to comply with strictly FDA regulations.

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Market Insight: Strategies for Overcoming Compliance Issues in the Pharmaceutical Industry


To successfully meet compliance demands, pharmaceutical manufacturers must develop, implement, and track the effectiveness of a company-wide compliance strategy. Key to that strategy is to adopt industry-specific enterprise software with functionality that supports Federal Drug Administration (FDA) requirements. Learn more about the criteria and recommendations you need to achieve compliance in the pharmaceutical industry.

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Case Study: Royal Bank of Canada


Royal Bank of Canada (RBC) is Canada’s largest bank and one of North America’s leading diversified financial services companies. To deliver regulatory-based courses and learning through a global, cost-effective channel, RBC replaced its homegrown learning management system (LMS) with a cost-effective, enterprise-wide solution, and consolidated its LMS for streamlined operations. Find out how they did it.

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Developing an Effective Document/Record Management Strategy for Today's Regulatory Environment


To better understand record management (RM) challenges related to regulatory compliance in the financial services and health care industries, it is important to know why the laws and acts were written and codified. This knowledge will help organizations understand why the RM team is creating and maintaining new records, and how report management can ease RM compliance challenges.

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The Sarbanes-Oxley Act and International Financial Reporting Standards


Recent legislation has bought about unparalleled emphasis on corporate governance and regulatory compliance. In the United States, the Enron and Worldcom affairs have led to a new law Sarbannes-Oxley. In Europe, the EU parliament has decided that all countries must streamline the laws for financial reporting in accordance with IFRS rules from IASC. Bringing organizations into compliance with new demands for corporate governance is having immediate and long-term effects. In this paper we discuss the current business environment, those facets of legislation impacting manufacturers and how QAD enterprise suite of applications can assist you in achieving corporate governance and regulatory compliance quickly, efficiently, and cost-effectively.

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Privileged User Management


IT managers feel overwhelmed with the rising tide of security threats they have to deal with in the face of an increasing regulatory burden. But they tend to overlook one particular area of IT security—the privileged access that they grant themselves or their colleagues in order to do their jobs. Learn how to make sure your IT systems are not impacted by the inadvertent or malicious actions of privileged users.

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Effective Operational Security Metrics


Due to the changing regulatory environment and the complexity of business today, organizations are facing increased accountability. Security risks, however, can often be difficult to measure and even more difficult to understand by people outside of the department. The key to demonstrating improvement is to translate security information in to business terms. Organizations must align, manage, and measure security around business operations.

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IT Infrastructure Trends in Banking


In the current regulatory environment, banks are facing two levels of challenges. While they are under pressure to expand beyond home territories, they also face stifling regulatory constraints. These restrictions are forcing banks to maximize on every capital expenditure they make. Such financial and regulatory reforms, in the face of the economic slowdown, have positive effects on quality assurance, governance and data management. But it also forces banks to hold capital that they would otherwise invest. This environment has made it vital for banks to sharpen their analytical and forecasting capabilities. Find out how the burden of regulation, expansion, cost optimization, and business transformation can be shared by an expert partner to foster an environment for growth.

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