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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.

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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

Are You on Track for 21 CFR Part 203 Compliance?


It’s old, it’s new, and it’s the future. Pedigree tracking regulations were originally passed into law through the Prescription Drug Marketing Act of 1987 (PDMA). After two decades of postponing enforcement, the US Food and Drug Administration (FDA) has lifted its final stay. Pharmaceutical companies are expected to be in compliance with 21 CFR Part 203 by the year 2011. Do you have what it takes for compliance?

21 cfr compliance  You on Track for 21 CFR Part 203 Compliance? It’s old, it’s new, and it’s the future. Pedigree tracking regulations were originally passed into law through the Prescription Drug Marketing Act of 1987 (PDMA). After two decades of postponing enforcement, the US Food and Drug Administration (FDA) has lifted its final stay. Pharmaceutical companies are expected to be in compliance with 21 CFR Part 203 by the year 2011. Do you have what it takes for compliance? Read More

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.

21 cfr compliance  to FDA’s publication in 21 CFR 820.40, Medical Device Manufacturers are required to have written procedures for the approval and distribution of documents. The approval procedures must ensure that the documents meet the requirements of the QS/GMP as well as adequacy for their intended use. Obsolete documents must be removed from circulation, and document approvals must include a signature and date. Removal (or prevention of use) of obsolete documents must also be verified. Written procedures Read More

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.

21 cfr compliance  (cGxP) and the FDA's 21 CFR Part 11, which sets down requirements for establishing audit trails for electronic documents. To combat counterfeiting, companies must introduce electronic pedigree controls. The SAP GRC Access Control application ensures SOD compliance for cGMP between different areas of operation, for example, production and quality management. Powered by SAP NetWeaver, SAP solutions for GRC ease compliance with Part 11 requirements for documentation and auditability, while providing a Read More

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.

21 cfr compliance  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. Read More

Getting a Return on Supply Chain Compliance


Change your paradigm by using supply chain compliance as a competitive tool to grow your business.  By viewing your organization from the inside out, you’ll make better decisions and better position your company against the competition by building strategic partnerships.

21 cfr compliance   Read More

Striking a Balance between Governance, Risk, and Compliance


Increasingly complex regulatory requirements in the health care industry have intensified pressures on health systems to assure compliance and operational governance while maximizing business performance. This study draws on a survey conducted by Healthcare IT News and Healthcare Finance News to share strategies that will improve governance, compliance, and business performance across today’s health care organization.

21 cfr compliance  healthcare job,healthcare provider,obama healthcare,free healthcare,healthcare industry,healthcare training,private healthcare,healthcare america,healthcare compliance,healthcare financial,healthcare information technology,healthcare news,healthcare plans,healthcare billing,healthcare consultant Read More

Governance, Regulation and Compliance


Companies must meet GRC criteria defined by internal and external policies, as failing to do so can have business and legal consequences. Although management of travel and entertainment (T&E) expenses is often seen as being of low importance for overall GRC, poorly managed T&E can lead to unforeseen issues with long-term business impact. See why using an external T&E management provider is the best way to adhere to GRC.

21 cfr compliance  Expense Management,Procurement,B2B,Legislation,Regulatory Compliance,Business Processes Read More

Selecting Manufacturing ERP for ISO 26000 Compliance


This white paper discusses the compelling business reasons for industrial companies to pay close attention to ISO 26000 and the UN Global Compact. It also explores the different ways that enterprise software like enterprise resources planning (ERP) and enterprise asset management (EAM) can be leveraged to help document compliance with the various requirements of the ISO standard.

21 cfr compliance  IFS,software administrativo,crm,erp,call center,on demand,annual report,supply chain,asset management,itil,ias,bpm,edi,csr,sales force Read More

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.

21 cfr compliance   Read More

ITAR Compliance with SAP GTS


If you deal in goods, services, or intellectual property included in the US Munitions List, you must ensure that all related transactions conform to International Traffic in Arms Regulations (ITAR). To answer this challenge, you need a solution that automates core ITAR processes—a solution that stores all your licenses and related documents where you can keep tabs on them.

21 cfr compliance   Read More

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.

21 cfr compliance  governance,risk,and compliance,compliance management systems,grc automation,enterprise grc,grc technologies,grc initiatives,and compliance technologies,and compliance automation,paperless document management software,inventory management software,document management software,digital asset management solutions,project management software Read More

IBM OpenPages Policy and Compliance Management


This video introduces the IBM OpenPages GRC Platform and, specifically, the Policy and Compliance Management module.

21 cfr compliance  risk management, enterprise risk management, risk management, governance, risk, and compliance, GRC requirements, GRC, corporate GRC, enterprise GRC, IBM OpenPages GRC Platform, enterprise GRC software, risk management solutions Read More

Compliance Exposures in ERP Systems Part 1


This paper examines key issues for CFOs and CEOs in managing ERP systems in the new world of SOX, IFRS, Basle II. While most IT management attention seems to be on document retention, reporting quality, and security, there are broader issues to be considered toward ensuring good governance and compliance with regulations such as Sarbanes-Oxley, IFRS and Basle II.

21 cfr compliance  1,000 users system is £21.7 million each year based on a five-year average. For all these reasons the compliance of any ERP system must be a focus for the CEO and CFO, and not assigned to IT as a technology project. Meta Group is one of the most respected IT observers and consultants with operations around the globe. Even if their figures are wrong by, say 10 - 15%, the numbers are still significant. ERP systems are major investments, and are made only after thorough analysis and planning by the Read More