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 21 cfr compliance


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

21 cfr compliance  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.

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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 » 21 cfr 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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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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Complying with US FDA Title 21 CFR Part 11 for the Life Sciences Industry


Compliance with US FDA regulations is a market requirement. Thus, among the nearly 1,500 installations of mySAP ERP software among pharmaceutical, medical diagnostics and devices, and biotechnology companies worldwide, it is vital to be aware of the functions and features of mySAP ERP that demonstrate technical compliance with US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule.

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Governance, Risk, and Compliance for Life Sciences Companies: Institutionalize Compliance to Reduce Costs and Increase Productivity


Issues of governance, risk, and compliance (GRC) affect nearly everything life sciences companies do. But you shouldn’t approach GRC in an ad hoc manner—implementing point solutions one after another in response to regulatory demands as they arise. This is inefficient and costly—and may result in non-compliance, due to lack of transparency. Learn how an enterprise-wide GRC approach to compliance management can help.

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Prophet 21


Prophet 21 enterprise software solution for wholesale distribution, utilizes a Windows-based platform and a Structured Query Language (SQL) Server database. This technology gives Prophet 21the familiarity of other Windows programs and can shorten the learning curve for new users. Prophet 21 includes the following functionality: order management, which features one-screen quote and order entry, customer relationship management (CRM), and pricing and availability features; inventory management, which can help reduce inventory levels while improving customer service; warehouse management, which provides flexible real-time control, and is designed to help minimize inventory losses, decrease shipping errors, and increase profitability; purchasing, which automates processes from a centralized location in order to optimize buying power and inventory levels across multiple warehouses and stocking locations; financial management, which includes real-time general ledger capabilities as well as cash collections and accounts receivable processes; and reporting and analysis. In addition, Prophet 21 is fully compatible with Trading Partner Connect, which can help streamline the commerce process between distributors, manufacturers/suppliers, and end users. Prophet 21 can be implemented either on site or remotely via an application service provider (ASP) or a hardware hosting option.

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Avoiding Information Overload: A Logical Approach to Managing Endpoint Security and Compliance


One of the biggest issues now facing corporations is regulatory compliance. As if corporate security threats weren’t enough, regulations such as Sarbanes-Oxley (SOX), the Gramm-Leach-Bliley Act (GLBA), and others now have long checklists of mandated requirements that must be adhered to—and thoroughly documented—by IT departments. Learn about a logical approach to managing the volumes of data required to prove compliance.

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Winning the PCI Compliance Battle


The payment card industry (PCI) Data Security Standard establishes common processes and precautions for handling credit card data. Although achieving PCI compliance can seem daunting, the requirements represent security best practices that should be observed by any organization with IT systems and data to protect. Learn about network scanning and security assessment solutions that can help you manage PCI compliance.

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Convergence, Collaboration, and Culture: The Evolution of Governance, Risk, and Compliance


Traditional governance, risk, and compliance (GRC) programs are siloed initiatives that are not equipped to manage the complexity of the dynamic modern regulatory and compliance environment. Organizations thus need to adopt a programmatic approach and tightly integrate risk management initiatives with ongoing business processes. BI and reporting can help, as well as provide a powerful mechanism for gaining a deep understanding of key factors that impact corporate performance.

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Customer Compliance Demands: Beast of Burden, or New Business Opportunity


Today, compliance pains come from three sources: government, large industrial or retail customers, and even smaller customers who are asking for unique delivery, packaging, assembly or other services. This white paper presents "compliance" as an enormous opportunity for the small to medium size business owner. Read it and understand the compliance demands within the distribution environment and how they affect your business.

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Provia Tackles RFID in a Twofold Manner Part Two: RFID Compliance


Provia's approach to radio frequency identification (RFID) compliance was to offer a bolt-on or drop-in product that works in conjunction with a company's existing logistics transactional software solution and process flows. This should put the suppliers back into control of prioritizing their IT projects because they could supposedly thereby be fairly easily and quickly made compliant with Wal-Mart or the DoD requirements for RFID. The next step for them would then be to look at how they can reap the benefits of RFID internally within their own operations.

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