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Software Functionality Revealed in Detail
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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

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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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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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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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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New DoD Regulations for the Cybersecurity Age: Implementing and Paying for the DFARS UCTI Safeguarding Contract Clause


The Department of Defense (DoD)’s acquisition clause on safeguarding unclassified controlled technical information (UCTI) affects DoD contractors of all sizes. Failure to comply with the requirements or to report a cyber incident now constitutes a breach and could result in fines or contract termination. Aronson’s white paper addresses many of the issues surrounding the new clause, including its implications for your business and how to comply.

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How Global Trade Management Can Assuage Your International Trade Worries


Globalization has lost its novelty. For most goods-driven enterprises it has become a matter of fact, just to stay in the game. However, the level of complexity that doing business globally entails can be daunting for professionals in charge of overseeing the supply chain—especially when the business needs to be nimble to keep ahead. Nimble can be painfully complex, but it doesn’t have to be

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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 guide their people, standardize their processes, and unify technology to embed GRC at all organizational levels.

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Ready for Change: Microsoft Dynamics Solutions in Chemical Manufacturing


The chemical industry is facing change from many directions—shifts in the economy, emerging markets, globalization of the supply chain, increasing regulations, and raw material price volatility. In response, chemical manufacturers need business solutions that adapt efficiently to new products and markets, vigorously protect intellectual property, meet increased obligations of environmental protection and continually adjust to new regulatory requirements.

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Automating Document-intensive Tasks with Workflow Software


In today’s business world, heightened privacy concerns and tightened regulations such as the US Sarbanes-Oxley (SOX) Act have forced organizations to improve their workflow and archival and records management processes. That's why many results-oriented organizations are now using workflow software—bringing together people, processes, and documents to improve efficiency, reduce costs, and meet compliance requirements.

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Data Privacy: Protecting the Core of your Business


Many companies are struggling to comply with a patchwork of regulations related to sensitive corporate information. As a result, companies are looking for new database security and auditing solutions to help prevent unauthorized access to confidential information—and to satisfy internal and external auditors—without the performance loss and insider security risk of traditional database management system (DBMS) logging approaches.

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