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 fda approval guidelines


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

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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

Web Content Management (WCM)

Web content management (WCM) systems manage content creation, review, and approval processes for web site content. This may include public Web sites (Internet) or private web sites (intranet or extranet). Use a WCM solution to organize and manage documents; provide content version control, collaboration utilities, and user- or document-level security. 

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Documents related to » fda approval guidelines

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.

fda approval guidelines  supports its mission, the FDA has defined Good Manufacturing Practices (GMPs) . Originally, GMPs were based upon the best practices of the industry. As technology and practices improved, the GMPs evolved as well. In the U.S., drug GMPs were formally introduced in 1963 and significantly rewritten in the 1970s. GMPs define a quality system that manufacturers use as they build quality into their products. For example, approved drug products developed and produced according to GMPs are safe, properly Read More

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 offer enterprises industry-oriented enterprise resource planning systems that are sound and compliance-ready.

fda approval guidelines  supports its mission, the FDA has defined good manufacturing practices (GMPs). Originally, GMPs were based on the best practices of the industry, and as technology and practices improved, the GMPs evolved as well. For instance, in the US, drug GMPs were formally introduced in 1963 and were significantly rewritten in the 1970s. GMPs define a quality system that drug manufacturers must use as they build quality into their products. For example, approved drug products that have been developed and produced Read More

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.

fda approval guidelines  Restrictions These criteria address FDA requirements for pharmaceutical and food manufacturing companies, including: Protect records to enable their ‘accurate and ready retrieval' ; Use computer-generated, time-stamped audit trails to record the date and time of record creation, modification, or deletion ; and Establish authority checks to ensure only authorized personnel can access the system and electronically sign or alter a record. Different administrators for different areas of workforce Read More

Sales and Operations Planning Part Three: Game Plan Guidelines


Effective game plans lead to improved firm performance and bottom line results. Metrics include reductions in stock-outs, delivery lead-time, missed shipments, partial shipments, expediting efforts, and improvements in customer service. This is an excerpt from the book Managing Your Supply Chain Using Microsoft Navision.

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Optimizing the Virtual Environment


As virtualized servers move to production environments, the threat of process and infrastructure breakdown is mounting, exposing IT departments to a number of virtualization risks. IT managers are looking for solutions that provide better control and a more comprehensive view of their virtual and physical IT environments. Follow these simple guidelines to choose the best-fit vendor for your virtualization solution.

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LaserComp


LaserComp can help to simplify compensation management for the enterprise. It enables compensation analysts to create plans, model impact, manage approval, and provide consistent results across the organization. LaserComp extends the capabilities of payroll and other human resource management systems (HRMS) to manage compensation administration. Web-enabled self-service features help managers to complete and review salary and bonus recommendations for their teams based on criteria defined by the organization.    

fda approval guidelines  lasercomp,lasercomp software,employee compensation software,incentive compensation software,workers compensation software,hr compensation software,sales compensation software Read More

It’s About Process (or the Ability to be Responsive) -- Part IV


Part III of this blog series introduced Webcom ResponsAbility, the on-demand workflow automation and business process management (BPM) solution. Anyone interested can take the product for a free trial test drive here. Other Real Life ResponsAbility Use Examples In addition to the examples described in Part III, another example of the ResponsAbility software in use can be found in Grayhill

fda approval guidelines  About Process (or the Ability to be Responsive) -- Part IV Part III of this blog series introduced Webcom ResponsAbility , the on-demand workflow automation and business process management (BPM) solution. Anyone interested can take the product for a free trial test drive here . Other Real Life ResponsAbility Use Examples In addition to the examples described in Part III , another example of the ResponsAbility software in use can be found in Grayhill, Inc. an electronics manufacturer from Lagrange, Read More

Why Life Sciences Companies Should Engage on Social Media


While most industries are rapidly adopting social media to engage with customers, the life sciences companies remain typically balk at extending social presence in a highly regulated environment. In view of recent Food and Drug Administration (FDA) guidelines on the responsibilities of life sciences companies monitoring social media, this paper intends to assist life sciences companies in determining the scope and potential impact of creating a social media engagement program.

fda approval guidelines  Food and Drug Administration (FDA) guidelines on the responsibilities of life sciences companies monitoring social media, this paper intends to assist life sciences companies in determining the scope and potential impact of creating a social media engagement program. Read More

Making SOP Training More Effective


Standard Operating Procedures (SOPs) are critical to efficient operations, quality control, and regulatory compliance. Yet many recent FDA violations have focused on firms’ failure to properly use SOPs. This paper reviews best practices for the life science industry for training on SOPs. Specifically, how the latest learning management technology has the potential to improve learner retention through automated assessments.

fda approval guidelines  compliance. Yet many recent FDA violations have focused on firms’ failure to properly use SOPs. This paper reviews best practices for the life science industry for training on SOPs. Specifically, how the latest learning management technology has the potential to improve learner retention through automated assessments. Read More

Make the Safe Choice


When it comes to workers’ safety, companies shouldn’t take any chances. The growing safety, security, and regulatory and reporting requirements are forcing many organizations to implement more sophisticated systems to monitor and manage their work environments. To help determine which mobile devices are approved and appropriate to use in your work environments, it’s important to have clear guidelines on what to look for.

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Vistaar Announces Record Year


While the jury is still out on whether the price management software market is lucrative and blossoming, at least price management solutions provider Vistaar Technologies recently announced that it closed 2012 with record customer growth and expanded implementations. Vistaar’s continued leadership in the beverage alcohol industry, with a strong presence in spirits, was marked by expansion into the

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Applying Lessons Learned in CRM Projects


The road to implementing customer relationship management (CRM) systems is fraught with risk and littered with failure. Paradoxically, reams have been written by industry practitioners explaining why CRM projects fail, yet the same patterns and mistakes are repeated—over and over again. While there is no magic bullet, following some simple guidelines can help assure CRM success for your organization.

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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.

fda approval guidelines  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