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Software Functionality Revealed in Detail
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 pharmaceutical regulatory compliance job description


A Focused Web-based Solution for Chemicals, Drugs, and Mill-based Industries
SSI shows deep understanding of the requirements for chemical, drug, and mill-based industries. Consequently, it has developed such must-have capabilities as

pharmaceutical regulatory compliance job description  challenge for chemical and pharmaceutical companies, owing to a humongous regulatory burden. The environmental regulations require strict monitoring and production restraints, since the manufacture and use of hazardous chemicals requires adherence to strict regulations, especially in North America and the European Union (EU). The chemical industry (and companies that rely on chemicals within their plants) thus have a myriad of new regulations to address. Restrictions, Requirements, and Other Constraints

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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 » pharmaceutical regulatory compliance job description

The Renewed Finance Function: Extending Performance Management Beyond Finance


The role of the finance team has changed recently, due to increased oversight from regulators, more active investors, and company-specific changes in business operations. What steps are companies taking to respond to the internal and external forces? Find out how finance often repairs core finance and operating activities, as exposed in the results of a survey and a series of interviews among senior finance executives.

pharmaceutical regulatory compliance job description   Read More

Managing Compliance with 21 CFR Part 11


Compliance with regulatory requirements is a business-critical need you must maintain. But meeting this need is more challenging with the creation of new regulations, such as 21 CFR Part 11, governing the use of software for secure data processing. But compliance is possible: an enterprise resource planning (ERP) system can help with audits, document and digital signatures, validation scripts, and other security needs.

pharmaceutical regulatory compliance job description   Read More

Compliance and Traceability in Manufacturing


Manufacturers focus on compliance and traceability initiatives for a variety of reasons, including compliance to regulatory mandates and mitigating risk of product recalls. Companies are increasingly focused on reducing manufacturing costs and particularly the cost of poor quality with end-to-end traceability of product and processes. Read here to know the key capabilities that help compliance and traceability initiatives.

pharmaceutical regulatory compliance job description   Read More

ERP System Manufacturing of Pharmaceutical and Botanical Products


A U.S.-based biotechnology company was looking for a fully integrated enterprise resource planning (ERP) solution to replace its underused and overly complex legacy system. The new system would need to include functionality typically found in engineer-to-order (ETO) and process ERP systems.

To find the right solution, the company turned to TEC for a custom evaluation and selection project.

Starting with a list of fifteen qualified solutions, TEC issued requests for information (RFIs) to each of the vendors. Based on the RFI responses, the company was able to compare the fifteen solutions and develop a shortlist of the 4 most promising ones for in-depth evaluation.

TEC also helped the company collect market data, and prepare scripts for formal demonstration session—a key component of the final selection process.



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Segregation of Duties and Its Role in Sarbanes-Oxley Compliance Issues


The Sarbanes-Oxley Act (SOX) requires publicly traded firms to demonstrate that their accounting and reporting practices are in compliance with regulatory standards. Section 404 of SOX addresses the concept and practice of segregation of duties—a key aspect of this legislation, and the focus of this article.

pharmaceutical regulatory compliance job description   Read More

PCI Compliance Cost Analysis


The Payment Card Industry Data Security Standard (PCI-DSS) was created by credit card companies to protect cardholder data, ensuring that merchants and service providers maintain the highest degree of information security. However, many retailers are still questioning its effectiveness and necessity in light of the high cost of compliance. Read this white paper to find out what this cost really means for your organization.

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The Convergence of Enterprise Governance, Risk & Compliance Software Solutions


The market for governance, risk, and compliance is still a maelstrom. Some vendors offer GRC software for the enterprise (eGRC), whereas others offer GRC for monitoring access and communications for compliance (IT-GRC). What’s more—both branches of GRC use technology to automate highly complex processes, while some GRC vendors offer capabilities that overlap both areas. To get a sense of the current attitudes toward GRC, Hypatia Research evaluated more than 20 GRC software vendors and interviewed more than 660 users of these applications. Read up on best practices, benchmarks, and vendor ranking.

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Achieving Efficient Governance, Risk, and Compliance (GRC) through Process and Automation


Newly available software platforms known as governance, risk, and compliance (GRC) technologies can help your business stay on top of the myriad procedures, tasks, and behaviors that bear upon compliance. This paper discusses the drivers behind the growing awareness of GRC information technology, introduces the elements of an effective automated GRC system, and suggests a low-risk, high-impact approach to launching GRC automation.

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Providing a Foundation for Regulatory Compliance


Regulations regarding digital information use, storage, and protection are meant to help maintain the integrity and security of public and private networks. Compliance measures such as the payment card industry (PCI), the Gramm-Leach-Bliley Act (GLBA), and others focus on the long-term retention and integrity of all data. Achieving secure, long-term data retention is easier with log management and incident response tools.

pharmaceutical regulatory compliance job description   Read More

Delivering Traceability in the Pharmaceutical Supply Chain


Counterfeit medicine is a major threat to the pharmaceutical industry. Seven percent of the medicine worldwide is counterfeit; however, advances in packaging and labeling technologies are coming to the industry’s aid. Pharmaceutical companies are using pilot projects to help labeling implementations throughout the supply chain to increase the availability of safe, licensed medicine and thwart the underground drug market.

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