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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

21 cfr part 11 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...
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Documents related to » 21 cfr part 11 fda


The Name and Ownership Change Roulette Wheel for Marcam Stops at SSA Global Part Two: Marketing By Invensys
IPS was hoping that the early product vision and venerable reputation that Marcam has in the process manufacturing market for providing plant-centric ERP

21 cfr part 11 fda  in areas such as 21 CFR 11 Part 11, which was introduced to anticipate the effects of electronic technology' on the drug discovery, development, and manufacturing processes. Accordingly, FDA regulations focus on two areas: 1) electronic records (i.e., ensuring accuracy, reliability, consistency, and visibility to changes in records, with time stamped audit trails) and 2) electronic signatures (i.e., authorized on-line signature that is legally binding). To that end, both future releases of Protean at the Read More...
3M Wraps Up HighJump, While Retalix Shops OMI International Part Two: Market Impact
Both HighJump's and OMI's customers should be pleased because these acquisitions should center their vendors’ supply chain execution products inside a larger

21 cfr part 11 fda  compliances such as FDA 21 CFR Part 11 rule. It should be a springboard for other vertical initiatives, but which other rigid competitive products will have long exhibited as well. Further, the vendor has been plagued with the perception of its poor amenability to the upper-end of the market with highly complex requirements, which might additionally be aggravated by not a great number of deployments on upper-range OS and database platforms. Nonetheless, over last couple of years, HighJump has acquired a 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

21 cfr part 11 fda  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...
The Many Faces of PLM Part Two: The Future of the PLM Suite
The future of the PLM Suite will include more applications that cover product-related functionality and further expand the benefits available. As the PLM Suite

21 cfr part 11 fda  capabilities to support FDA 21 CFR Part 11, an important requirement in the Life Sciences industry. This focus is increasingly important as new regulations are being unfurled, such as WEEE (Waste Electronic and Electrical Equipment) and the TREAD (Transportation Recall Enhancement, Accountability, and Documentation), whose requirements span large segments of the product lifecycle. PLM focus on regulatory and compliance issues is not entirely new, as SAP has long included Environmental Health and Safety Read More...
They do it like that in the Balkans-Select and deploy ERP, I mean (Part II)
The Part I of this blog topic concluded with SAP's supremacy in the upper-end of the regional market. What also helps SAP ERP [evaluate this product] is a

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What Can Manufacturers Do in a Tough Economy? - Part II
Part I of this blog series outlined the first three suggested

21 cfr part 11 fda   Read More...
The Power of Knowledge -- Knowledge is Power (Part 2)
Part 1 of this blog series introduced the need for knowledge management (KM) software applications as part of a more comprehensive and strategic service

21 cfr part 11 fda   Read More...
Mega-vendors Warming Up to the Cloud - Part 2
Part 1 of this blog series depicted the three evolutionary phases (or waves) of software as a service (SaaS) and cloud computing adoption. The article ended

21 cfr part 11 fda   Read More...
Nothing Succeeds Like Success(Factors) - Part 2
Part 1 of this series introduced SuccessFactors, a public provider of software as a service (SaaS) talent management solutions. My post first analyzed the

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Frankie Does ERP, Part 2
[Editor’s note: Frank is not a composite character. He is a real person, employed at a real company. I’ve changed certain identifying particulars at his request

21 cfr part 11 fda   Read More...
Taking Stock of TAKE Supply Chain Solutions - Part 2
Part 1 of this blog series introduced TAKE Supply Chain, a supply chain management (SCM) division of TAKE Solutions, Ltd. The TAKE Solutions parent company is a

21 cfr part 11 fda   Read More...
Mega-Vendors Warming Up to the Cloud - Part 3
Part 1 of this blog series depicted the three evolutionary phases (or waves) of software as a service (SaaS) and the adoption of cloud computing. The post ended

21 cfr part 11 fda   Read More...

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