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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

Cloud Computing Forecast—50% Chance of 483s! 3 Things You Should Do To Weather the Storm


And unfortunately, many casual users do not understand the full impact of their actions in the new computing frontier called the cloud. For those in life sciences companies, deploying solutions in the cloud may lead to unintentionally violating FDA regulations if the proper steps have not been taken to ensure FDA compliance.

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Compliant Manufacturing Operations in Life Sciences Companies: Compliant Operations to Lead the Competition


For many life sciences organizations, a key impediment to compliant manufacturing operations remains the disconnect between enterprise and plant systems. This results in unsynchronized business processes and inadequate use of resources, which in turn increases the risk of non-compliance and inadequate quality of finished products. Find out why simply connecting systems is not enough to fully overcome these challenges.

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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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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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How Is Regulatory Stress-testing Shaping the Future for Banks?


Out of the shortcomings exposed in banks’ traditional risk management processes during the recent global financial crisis comes the critical need for improvement. One particular high-profile risk management requirement is enterprise stress-testing, and it is subject to additional regulatory burdens and wider scrutiny. Stress-testing is moving the banking industry into more involved and invasive analysis. Find out how.

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Tenrox


Since 1995, Tenrox has provided on-demand software solutions for enterprise fragmentation, work projects, and regulatory scrutiny. Tenrox's solutions, with Statement on Auditing Standards (SAS) 70 Type II certification, focus on best practices and work policies, regulatory compliance, and real-time reporting. The company has served over 800 organizations in 50 countries, including Blue Cross Blue Shield, First National Bank, Hydro-Québec, The Pentagon, and Wyeth. Tenrox is based in Pasadena, California (US), and has offices in Montreal and Toronto (Canada), and London (UK).

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Dealing with Food Industry Pressures


Small and medium food and beverage companies have the same regulatory requirements as large companies, but with significantly fewer resources with which to address them. Companies need systems that can provide comprehensive traceability information at the touch of a button.

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Simplifying Secure File Transfer: Selecting a Best-in-class File Transfer Management Solution


Corporations share data with a variety of remote offices, trading partners, customers, and regulatory agencies. Sensitive data is transferred to and from entities around the world billions of times a day. Security breaches are frequently in the news, with reports of compromised customer data. However, business-to-business (B2B) workflow breakdowns are more likely to occur—and are potentially just as harmful.

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Health Means More


Medical and health care regulatory norms are tightening worldwide, and all key stakeholders, including payers, providers, and patients are becoming more discerning with regard to the quality of products and services delivered. As a result, the health care and life sciences (HLS) sector is increasingly leaning on analytics to find solutions for improving the delivery of health care—and improving the business of health care.

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