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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.
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 gmp regulations


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 regulations  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 regulations

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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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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Vendors Jostle and Profess Economic Stimulus Readiness - Part II


Part I of this blog series tried to analyze not only the opportunity but also the many related strings attached stemming from the American Recovery and Reinvestment Act of 2009 (ARRA), a.k.a. the Economic Stimulus Plan. The inspiration came from my attendance of the Deltek Insight 2009 user conference last May, where Deltek decided to fill a market need by convening a separate

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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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What's Really Driving Business Intelligence?


Typical explanations given for increased spending in business intelligence include, meeting government regulations, managing information overload, tracking corporate goals, and improving competitive response. However, a deeper drive for BI stems from the need to quantify the intangibles that underlie the market value of a business.

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transavia.com Selects Kronos AD OPT for Crew Rostering


One of the lesser talked about business divisions of Kronos Inc. is Montreal, Canada–based AD OPT, a provider of crew planning optimization solutions for the airline industry, which Kronos acquired in 2004. The company has been in this space for more than 25 years and its core focus is to deliver customized solutions for the tricky task of flight crew planning and scheduling for airlines whose aim

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Managed File Transfer: The Need for a Strategic Approach


A secure and accurate flow of information in your supply chain operations has never been more critical—and complex. Digital transfer of unstructured information is a security risk, for both confidentiality and compliance, and traditional file transfer methods are now falling short. A managed file transfer solution combining hardware, software, and networks can meet your demands for visibility, security, and compliance.

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How to Achieve Regulatory Compliance with E-mail and Internet Content Security Policy Enforcement


The maze of regulations governing electronic data has never been more complex. Various regulatory bodies, as well as international, regional, and national governments, have different requirements for handling electronic data. Get an in-depth look at compliance regulations, particularly the US Sarbanes-Oxley Act (SOX), that impact IT managers, and learn about best practices for managing your electronic messaging content.

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A Layered Security Strategy for Preventing Data Leakage, Theft, and Insider Abuse


Threats to data content posed by insiders. Compliance regulations entailing stringent data controls. It’s hardly surprising companies need to find more secure methods for keeping confidential data under lock and key. Learn about managing security challenges across three important layers of your IT infrastructure, and how database activity monitoring (DAM) and database auditing and protection (DAP) can help you.

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Managing Performance, Risk, and Compliance for Better Business Results


Confronted by globalization and volatile markets, today’s companies face a challenging and often risky business climate. Explore how to ensure alignment between your company's strategic objectives and risk management/compliance policies; how to mitigate all types of business risk and maintain a proper risk/reward balance; and how to ensure continuous compliance with regulatory requirements and internal policies.

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