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Documents related to » fda guideline


ERP Selection Series: Requirements for an FDA-regulated Environment
The FDA imposes strict process controls on food and pharmaceutical manufacturers for good reason. Consequences of mistakes are hefty—ranging from costly recalls and lawsuits to illness and death. Food and pharmaceutical manufacturers need to keep profitability high while maintaining strict quality-control standards. See how your ERP software can make the difference between process control and business-crippling process instability.

FDA GUIDELINE: White Paper Description: The FDA imposes strict process controls on food and pharmaceutical manufacturers for good reason. Consequences of mistakes are hefty—ranging from costly recalls and lawsuits to illness and death. Food and pharmaceutical manufacturers need to keep profitability high while maintaining strict quality-control standards. See how your ERP software can make the difference between process control and business-crippling process instability. ERP Selection Series: Requirements for an
3/25/2013 12:06:00 PM

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 GUIDELINE: Complying with US FDA Title 21 CFR Part 11 for the Life Sciences Industry Complying with US FDA Title 21 CFR Part 11 for the Life Sciences Industry Source: SAP Document Type: White Paper Description: 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
11/23/2006 4:11:00 PM

ERP Selection Series: Requirements for an FDA-regulated Environment
The FDA imposes strict process controls on food and pharmaceutical manufacturers for good reason. Consequences of mistakes are hefty—ranging from costly recalls and lawsuits to illness and death. Food and pharmaceutical manufacturers need to keep profitability high while maintaining strict quality-control standards. See how your ERP software can make the difference between process control and business-crippling process instability.

FDA GUIDELINE: White Paper Description: The FDA imposes strict process controls on food and pharmaceutical manufacturers for good reason. Consequences of mistakes are hefty—ranging from costly recalls and lawsuits to illness and death. Food and pharmaceutical manufacturers need to keep profitability high while maintaining strict quality-control standards. See how your ERP software can make the difference between process control and business-crippling process instability. ERP Selection Series: Requirements for an
3/25/2013 12:06:00 PM

A Quality and Compliance Training Road Map for Emerging FDA-regulated Companies
A Quality and Compliance Training Road Map for Emerging FDA-Regulated CompaniesEmerging life science companies face the same compliance and regulatory pressures as larger ones. Companies that outsource sales and operational functions need to disseminate training on key policies, procedures, and regulations to a wide audience—without the benefit of a dedicated training team. These companies demand solutions that automate the quality training effort without compromising the entire quality program.

FDA GUIDELINE: Road Map for Emerging FDA-regulated Companies A Quality and Compliance Training Road Map for Emerging FDA-regulated Companies Source: Eduneering Document Type: White Paper Description: A Quality and Compliance Training Road Map for Emerging FDA-Regulated Companies Emerging life science companies face the same compliance and regulatory pressures as larger ones. Companies that outsource sales and operational functions need to disseminate training on key policies, procedures, and regulations to a wide
6/12/2012 4:13:00 PM

Food Safety, Government Regulations, and Brand Protection
Many food companies are investing significant funds in building awareness for their brands in the market, which can pay off amply in competitive, commodity markets. One highly publicized recall, however, can turn an established brand asset into a liability.

FDA GUIDELINE: and Drug Administration ( FDA ) and US Department of Agriculture ( USDA ), that are responsible for regulating food products. These agencies help to ensure that foods are safe to eat, and that they do not contain any harmful additives. Correct labeling of food products is strictly enforced, and some countries now exercise strict guidelines relating to product advertising. Food control and safety will only increase with the closer linking of food supplies among countries and regions, especially in light
11/2/2006

ERP Issues for the Midsized Life Sciences Company
ERP Issues for the Midsized Life Sciences Company. Find White Papers, Case Studies, and Other Resources Associated with the 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 GUIDELINE: be an opportunity. The FDA is permitting manufacturers to benefit from emerging technologies to streamline record keeping and compliance. This technology can increase the usability of the information gathered by integrating both business processes and audit functions, without compromising the quality of regulatory compliance. The opportunity can be significant. Life Science companies should see Part 11 as an opportunity to improve business practices. Benefits may include: Lowered cost of data collection
4/4/2008 4:15:00 PM

Five Critical Software Requirements for Improved Product Safety and Traceability
Food, beverage, chemical, and pharmaceutical companies are being forced to leverage new technology to meet evolving product safety and lot traceability requirements related to stringent FDA and USDA regulations. For you to take advantage of these sophisticated new tools, there are five critical software requirements your enterprise resource planning (ERP) software should meet. Download this white paper to find out what they are.

FDA GUIDELINE: requirements related to stringent FDA and USDA regulations. For you to take advantage of these sophisticated new tools, there are five critical software requirements your enterprise resource planning (ERP) software should meet. Download this white paper to find out what they are. Five Critical Software Requirements for Improved Product Safety and Traceability style= border-width:0px; />   comments powered by Disqus Related Topics:   Enterprise Resource Planning (ERP),   Regulatory and Compliance
4/12/2012 2:58:00 PM

Performance Made Perfect: Optimize Materials Management and Logistics Operations
In this challenging economy, standards for materials flow are critical to thriving in the global automotive industry. Successful suppliers know how to meet Materials Management Operations Guideline/Logistics Evaluation (MMOG/LE) standards. MMOG/LE is a self-assessment for material and logistics control used to evaluate production, parts and service, and more. Learn how it can help you succeed in the automotive market.

FDA GUIDELINE:
10/20/2008 2:05:00 PM

Digital Signatures Good from Arctic to Rio Grande
The U. S. Congress passed a bill making digital signatures legal in commerce. Canada's provinces are in the midst of taking the same action

FDA GUIDELINE: electronic contracts, digital signatures, e signature software, esignature, electronic signature pads, electronic signature software, signature pads, free electronic signature, electronic signature pad, digital signature software, digital signature pads, silanis, epad interlink electronics, electronic signature capture, epad signature, creating electronic signature, electronic signature contract, legal signatures, sign pdf electronically, signature capture, digitally signed pdf, pdf signatures, personal digital signature, advanced electronic signature, digitally sign pdf document, digitally .
7/10/2000

Plex Systems at a Crossroads: Part 2 » The TEC Blog
yet to solve the FDA validation puzzle in the medical devices, drugs, and some food manufacturing environments, given its public cloud offering and continual enhancements (that might change the consistency of validated process outcomes). Of all of the possible opportunities for Plex, the vendor’s focus on medical devices or other FDA-regulated environments is surprising. I get the track-and-trace angle, but still, why target a vertical that just invites this type of serious inquiry in areas that are

FDA GUIDELINE: Lean Manufacturing, Manufacturing, Plex Manufacturing Cloud, plex online, plex systems, PowerPlex, TEC, Technology Evaluation, Technology Evaluation Centers, Technology Evaluation Centers Inc., blog, analyst, enterprise software, decision support.
02-07-2013

Process-based Governance, Risk Management, and Compliance
The right balance of automated processes with paper records and manual, human interaction is necessary to keep costs under control with a flexible yet controlled set of procedures. The strategic software category, governance, risk management, and compliance, is poised to help.

FDA GUIDELINE: paper by Olin Thompson, FDA Compliance for the Life Sciences ). In any organization, evaluation of the characteristics of operations, products, and so forth will reveal the mix of standard versus exceptional circumstances. The most effective procedures will allow computer systems to assist in repetitive operations. At the same time, computers can integrate manual or semi-manual approaches to exceptions, which should be captured in a digital form to facilitate the storing and retrieving of documents,
7/23/2008


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