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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.
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 fda regulatory compliance certification


How a Leading Vendor Embraces Governance, Risk Management, and Compliance
SAP AG has long committed to placing compliance at the core of its product suite, as the vendor has recognized the growing role of enterprise systems in

fda regulatory compliance certification  Food and Drug Administration (FDA) requirements for pharmaceutical companies; and Basel II for the banking sector. This is part one of the two-part article How a Leading Vendor Embraces Governance, Risk Management, and Compliance . In part two, SAP's GRC product suite will be discussed in more detail, and speculation will be made on the product suite's potential for success within the vendor's current and prospective customer base.

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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 » fda regulatory compliance certification

What Could Process Manufacturers Do Better in PLM?


Part 1 of my recent blog series, Filling the Holes and Breaking Down Artificial Walls in a Process PLM Solution Set, established that the product lifecycle management (PLM) software market for process industries (i.e., food @ beverage, life sciences, chemicals, paints, consumer products, etc.) has not been well-defined as compared to its counterparts in the discrete widgets manufacturing and

fda regulatory compliance certification  Food and Drug Administration (FDA) recalls is inaccurate label content. The current artwork process can be best described as changing tires on a moving car. Since design, proofs, and printing are outsourced, the lead times and chances of introducing errors are increased. With each formula change, claims or product attribute content are likely to change as well. With each upcoming promotion or season, digital assets or claims may change. As the owner of the artwork, companies can minimize the cost of Read More

Fighting Terrorism with Global Trade Management


The challenge for government and industry is to secure trade without impeding growth. Therefore, there is a greater need for timely information updated by knowledgeable sources of compliance and regulation issues. Global trade management software appears to be the best solution.

fda regulatory compliance certification  to be made to FDA within four hours; and prior notice of food import shipments before allowed entry to the US Patriot Act of 2002 This Act, signed into law by the US president, requires that financial institutions know their customers and, to the greatest extent possible, their customers' customers. (Source: TradeBeam ) One should notice a multitude of complex interactions between the global trade flows within a secure supply chain. Namely, across few dozens of required pertinent processes, global trade Read More

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 potency controls, container movements, top-down and bottom-up traceability, and controls for customs and excise, shelf life, and location validation.

fda regulatory compliance certification  authorities such as the FDA in the US; Hazard Analysis Critical Control Points (HACCP) in Canada; the Medicines and Healthcare products Regulatory Agency (MHRA), Her Majesty's Revenue & Customs (HM C&E), Control of Substances Hazardous to Health Regulations (COSHH), and the Food Standards Agency (FSA) in the UK; Health and Safety Statutory Instruments in Ireland; and European Food Safety Inspection Service ( EFSIS )/ British Retail Consortium (BRC) standards. (EFSIS is a premier third-party independent Read More

Will Your HACCP Foundation Crumble?


Complying with current good manufacturing processes (GMPs) is no easy task for food manufacturers. Companies that don t have a solid foundation to help with quality control procedures, audit trails, and product traceability and recall are at an even greater disadvantage. Find out how an enterprise resource planning (ERP) solution can help with food safety compliance—so it's your cookie that crumbles, not your foundation.

fda regulatory compliance certification  Fault Tree Analysis | FDA Haccp | Food Analysis | Food and Drug Administration | Food Development Centre | Food Handling | Food Hazard Analysis | Food Hygiene | Food Hygiene Course | Food Hygiene Training | Food Microbiology | Food Quality | Food Quality Control | Food Safety | Food Safety | Food Safety and Sanitation | Food Safety Audit | Food Safety Audits | Food Safety Consultancy | Food Safety Consultant | Food Safety Consultants | Food Safety Hazard | Food Safety Management | Food Safety Management Read More

Aligning Financials for Improved Business Value and Compliance


In Align Financial Processes and Systems for Better Business Value and Compliance, learn how an integrated, life-cycle approach to financial manage...

fda regulatory compliance certification  Financials for Improved Business Value and Compliance If your company uses disparate software systems, spreadsheets, and manual workarounds to drive financial outcomes, you may be stifling your business. In Align Financial Processes and Systems for Better Business Value and Compliance , learn how an integrated, life-cycle approach to financial management can dramatically improve your financial analysis, performance, and reporting. You'll discover how the right financial approach can help you gain Read More

Rootstock ERP for SMB Certification Report


Rootstock by Rootstock Software is now TEC Certified for online evaluation of enterprise resource planning (ERP) for manufacturing (SMB) solutions in the ERP Evaluation Center. The Rootstock solution is natively built on the Salesforce platform, and thus takes advantage of everything the platform has to offer—from global search, to industry leading security, to reporting and dashboards, to mobile support for any mobile platform. Download the Rootstock certification report now for product analysis and in-depth analyst commentary.

fda regulatory compliance certification  Rootstock, Rootstock Software, ERP for SMB, ERP software for SMBs, ERP for SMB manufacturing, enterprise resource planning for SMBs Read More

Compliance: A Work in Progress


There’s no magic bullet for compliance success—even the most experienced organizations use a combination of reliable processes and proven technologies to get the job done. But identifying, designing, and executing the right internal controls to meet compliance standards in a large, global company can be arduous and expensive. The systems you use to support compliance efforts must be implemented well. Find out more.

fda regulatory compliance certification   Read More

Ramco OnDemand ERP Certification


Ramco OnDemand ERP is a full-function SaaS ERP product for the small to medium business (SMB) environment. The entire product is Web-based, accessible by your web browser, and fully supported via the Web.First Impressions The forms layouts and many of the detail screens allow for data field relocations and reconfigurations via drag and drop. The default color schemes are easy on the

fda regulatory compliance certification   Read More

TEC Certification Explained


If you’ve been to the TEC Vendor Showcase recently, you’ve probably seen this symbol. If you wondered what it means, you might have clicked it, and read this: “TEC Certified Vendors have met the stringent requirements set forth by our analysts. Associate vendors have taken the first step toward their TEC certification by completing our extensive request for information (RFI).” Concise

fda regulatory compliance certification   Read More

Governance, Risk, and Compliance Management


Governance, risk, and compliance (GRC) issues are hot topics today, thanks to high-profile stories about companies that failed to meet regulatory requirements. In each case, executives were held accountable, stock prices dropped, and brand image suffered. Find out about cross-enterprise GRC solutions that can make it easier to monitor compliance and risk effectively, and adjust to changing regulatory mandates.

fda regulatory compliance certification  Risk, and Compliance Management Governance, Risk and Compliance Management: Realizing the Value of Cross-Entreprise Solutions If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. Founded in 1972, SAP has a rich history of innovation and growth as a true industry leader. SAP currently has sales and development locations in more than 50 countries worldwide and is listed on several exchanges, including the Frankfurt Stock Exchange 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.

fda regulatory compliance certification  Practices (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 Read More

Standard & Poor's Announces Security Certification


After exposing numerous customers to embarrassing security vulnerabilities, S&P announces a security certification program.

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TEC Product Certification Reports Now Available


We've begun publishing a new type of report (free download) called a Product Certification Report. These have been in the works for a while so I'm very happy to announce the first two are now available. I'll post the links below and then explain what these reports are. Meridian Global LMS (an enterprise learning management system [LMS] as certified by Sherry Fox) Pronto Software's Pronto Xi

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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.

fda regulatory compliance certification  customer compliance demands,compliance in distribution,electronic data interchange,compliance demands involving customization,small to medium distributor,Sunrise Technologies Read More