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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

fda  ERP/CRM Software to Facilitate FDA Compliance Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. With more than 30 years' history and as one of the first software vendors to develop an enterprise resource planning (ERP) solution, SYSPRO is the longest standing and largest independent, international vendor of enterprise business solutions. Source : Read More...
Discrete Manufacturing (ERP)
The simplified definition of enterprise resource planning (ERP) software is a set of applications that automate finance and human resources departments and help manufacturers handle jobs such as or...
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Documents related to » fda


Expandable Case Study: Thermage, Inc.
After receiving US Food and Drug Administration (FDA) approval for its ground-breaking product, medical technology startup Thermage, Inc., was looking to

fda  up production and maintain FDA compliance. Read More...
RFID in Healthcare--A Whole Industry of Value
This article talks about recent and expected FDA regulations and how RFID can help meet those requirements while improving supply chain performance.

fda  of Value Introduction The FDA is not only responsible for the protection of citizens and consumers, but also is an active partner with industries such as food, pharmaceuticals, medical devices, etc., in pursuit of industry best practices. $49 billion of imports of pharmaceuticals enter this country every year. The pressure is on from consumers and industry to protect their own interests. These represent sometimes conflicting goals of protection. Protect the consumer, yet protect brand integrity and the Read More...
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

fda  Road Map for Emerging FDA-regulated Companies 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 audience—without the benefit of a dedicated training team. These companies demand solutions that automate the quality training effort without 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

fda  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...
iMaint
DPSI's iMaint is a comprehensive enterprise asset management (EAM) system. Customers use iMaint to manage manufacturing and processing plants, facilities

fda  computer with Internet access• FDA Module—helps manage compliance with FDA 21 CFR 11 regulationsDPSI also offers PMC, computerized maintenance management system (CMMS) software for individual computers and small networks. Read More...
Databases and ERP Selection: Oracle vs. SQL Server
The database is an essential component of enterprise applications such as enterprise resource planning (ERP) and enterprise asset management (EAM). This white

fda  oracle vs. sql server,to sql,sql to,sql server,server sql,sql for sql server,sql server server,about sql server,sqlserver,server 2008,2008 sql,sql 2005,2005 sql,sql server 2008 sql server 2008,about sql server 2008 Read More...
What PAS 55 Means for EAM Software Selection
PAS 55 compliance is a priority for asset-intensive companies that must maximize asset value. Learn how enterprise asset management (EAM) software can

fda  PAS 55 Means for EAM Software Selection PAS 55 compliance is a priority for asset-intensive companies that must maximize asset value. Learn how enterprise asset management (EAM) software can facilitate the practices in this specification, including the most demanding requirement—asset lifecycle management encompassing all asset stakeholders including contractors, suppliers, engineers as well as internal users. Read More...
EAM Selection Criteria: Focus on Usability
In selecting enterprise asset management (EAM) software, usability ought to be a major consideration in your decision. Download this white paper for expert

fda  selection criteria,usability enterprise asset management,erp,criteria,it asset management,asset management it,asset management,what is asset management,management asset,about asset management,asset it management,asset management for it,resumes,it resource management,help desk Read More...
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

fda  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. Read More...
What Keeps EAM/CMMS Away From PLM?
Today, many assets are designed and manufactured with the help of product lifecycle management (PLM) tools and systems, which contain highly valuable product

fda  Keeps EAM/CMMS Away From PLM? Today, many assets are designed and manufactured with the help of product lifecycle management (PLM) tools and systems, which contain highly valuable product definition information for enterprise asset management (EAM) and computerized maintenance management system (CMMS) operations. That being said, if there is a way to tie the two systems (EAM and PLM) together, the result will be beneficial to original equipment manufacturers (OEMs), asset owners, and third-party Read More...
Maintenance Connection Onsite/Online: CMMS – EAM Competitor Analysis Report
The EAM knowledge base is geared toward groups that need to analyze requirements for a system, which supports maintenance management tasks. Asset management

fda  Connection Onsite/Online: CMMS – EAM Competitor Analysis Report The EAM knowledge base is geared toward groups that need to analyze requirements for a system, which supports maintenance management tasks. Asset management systems typically enable planning, controlling, and monitoring of physical asset events. This knowledge base includes criteria for comparing general computerized maintenance management system (CMMS) functionality, fleet maintenance, workflow, reporting, and other areas that Read More...
PTC Submits Test Data to FDA’s Global UDI Database
Working with the FDA and major medical device manufacturers, PTC has developed a Global Unique Device Identifier Database (GUDID) submission solution that such

fda  PTC worked with the FDA and major medical device manufacturers to develop a GUDID submission solution. Built on the PTC Windchill product lifecycle management (PLM) platform, the PTC UDI solution is a preconfigured software solution, validated in accordance with 21 CFR Part 11 requirements, designed to help medical device manufacturers meet the needs of UDI submissions as quickly and effectively as possible. Any PLM software vendor that targets the medical devices industry will have to follow PTC’s Read More...
Drug Pedigree Guidelines and How Software Can Help
Drug manufacturers and retailers are tightening their data collection and reporting processes to meet new US Food and Drug Administration (USFDA) guidelines

fda  Food and Drug Administration (FDA) has issued guidelines covering cradle-to-grave tracking requirements that pharmaceutical companies must comply with for the drugs they produce. We'll look at a brief description of the pedigree guidelines and compliance options. What Are Pedigree Guidelines? Simply stated, the FDA's pedigree guidelines require data to be captured at each stage of the production and distribution process, until the drugs reach the customer or end user. The players principally affected Read More...
IFS Applications: CMMS – EAM Competitor Analysis Report
The EAM knowledge base is geared toward groups that need to analyze requirements for a system, which supports maintenance management tasks. Asset management

fda  Applications: CMMS – EAM Competitor Analysis Report The EAM knowledge base is geared toward groups that need to analyze requirements for a system, which supports maintenance management tasks. Asset management systems typically enable planning, controlling, and monitoring of physical asset events. This knowledge base includes criteria for comparing general computerized maintenance management system (CMMS) functionality, fleet maintenance, workflow, reporting, and other areas that touch upon asset Read More...

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