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Software Functionality Revealed in Detail
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 gmp compliance


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

gmp compliance  access control   B) GMP Compliance The following functionality includes production process controls, laboratory controls, and labeling procedures to help manufacturers comply with GMPs. Comment field for specified raw materials Hazardous materials threshold ranges are based on component percentages and tolerance ranges Hazardous materials can be located by expanding formulas Prints customized labels containing product and hazardous data Conflicting hazard statements are identified and prioritized

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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 compliance

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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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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Using Demand to Modulate Consumer Packaged Goods Supply Networks


Traditionally, the consumer packaged goods supply has been driven to market mostly by upstream manufacturers. But progressive companies are realizing the enduring value of being driven by the market, and they are starting to use demand as a guiding light.

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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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Make Compliance Work for You


Compliance is often treated as a necessary evil that creates costs, disruption, and complexity. But these pains often result from dealing with compliance in a clumsy way due to a lack of resources and the absence of a compliance strategy. There’s a better way: using standards-based data management solutions that integrate with existing infrastructure and leverage automation to embed compliance at all levels. Find out how.

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Enhanced Courseware for Compliance and Risk Mitigation Training from Skillsoft


Skillsoft announced that it has added new content courses to its compliance and risk mitigation courseware collection. Skillsoft's compliance courses—available on demand—are aimed at preparing individuals for exams and meeting regulatory requirements. The courses have been compiled in collaboration with subject matter experts and cover organization-specific legal requirements as well

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Improving Regulatory Compliance with Encryption


As a bedrock element of any sound corporate data protection strategy, encryption protects valuable company data, whether it is at rest, in transit, or in use. Advanced encryption algorithms coupled with faster processors now make it possible to transparently encrypt and decrypt entire drive volumes, massive amounts of data on storage area networks (SANs), and other large-volume data stores.

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How to Prevent Data Leaks and Achieve PCI Compliance


The greatest threat on the Internet involves increased data theft, data leakage, and targeted attacks for the purpose of stealing confidential information. To combat this, the payment card industry (PCI) has created a data security standard (DSS) that holds all merchants—regardless of size—to much higher standards of performance when it comes to protecting customers’ financial and personal information.

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Vulnerability Management for GLBA Compliance


The security provisions of the US Gramm-Leach-Bliley Act (GLBA) are complex and process-intensive, and non-compliant financial institutions and their officers have suffered penalties as a result. With QualysGuard’s vulnerability management and policy compliance solution—including on-demand auditing capabilities—financial institutions can easily meet the key security guidelines that are detailed in the GLBA.

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Validate and Enforce Change Process for SOX Compliance


If the auditors came knocking, would you be prepared? When they do come, you’ll need to be ready to answer some tough questions regarding your change management processes. Implementing and assessing change management controls for Sarbanes-Oxley Act (SOX) compliance in the US can be a very expensive and time consuming process. Find out how you can reduce the SOX burden by improving the way you manage your change processes.

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