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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 compliant  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
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Documents related to » 21 cfr part 11 compliant


HIPAA-Watch for Security Speeds Up Compliance Part One: Vendor and Product Information
HIPAA-Watch for Security is a tool designed to guide organizations through the risk analysis required by the Health Insurance Portability and Accountability Act

21 cfr part 11 compliant  Suite 300, Annapolis, MD, 21401 Product Name HIPAA-Watch for Security Key Features NIST 800-26 compliant, automatic reporting, auditing, multi-user response system, life cycle management, automated financial calculations: annual loss expectancy, cost benefit analysis, return on investment; customizable Company URL www.riskwatch.com Product URL www.riskwatch.com/hipaa.asp Customer Contact 800-448-4666 Investor Inquiries invest@riskwatch.com This is Part One of a two-part note. Part One provides a vendor Read More
Managing the Aches and Pains of Long Cycle Times: Automating Controls for Pharmaceutical Manufacturers
One of the biggest challenges (or business pain points) for pharmaceutical manufacturers (or life sciences companies) is the long cycles that are required for

21 cfr part 11 compliant  address compliance issues, including 21 CFR Part 11. How does 21 CFR Part 11 relate to product R&D and approvals? For all of the processes involved in getting a drug to market, strict policies must be established and followed by a company regarding the use of electronic records. Each step of product R&D and approval processes must be, according to the dictates of 21 CFRR Part 11, consistent, reliable, and repeatable—in other words, each version of every document must be archived and easily retrieved 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

21 cfr part 11 compliant  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 suit if they haven’t already done so. Read More
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 compliant  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
Grape Escape 2013: Customer Value a Priority for Both SYSPRO and UNIT4-Part 2
This is part 2 of a 2-part blog post on Grape Escape 2013, with my analyst take on the announcements and conversations with UNIT4 at the recent analyst event in

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Up Close and Personal: Martin Schneider, Senior Director of Communications at SugarCRM-Part 2
In part one of my interview with Martin Schneider, Senior Director of Communications at SugarCRM, we discussed the history of SugarCRM and the open source

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The Wizardry of Business Process Management: Part 5
Part 1 of this blog series started a lengthy discussion about the value proposition and parts-and-parcels of business process management (BPM), with an ensuing

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To SaaS or Not, Is That a Question? - SaaSy Discussions (Part IIa)
The first part of this blog series described the opportunity for software as a service (SaaS) or on-demand enterprise applications, especially in the current

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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

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To SaaS or Not, Is That a Question? - SaaSy Discussions (Part IIc)
The first part (Part II) of this blog series described the opportunities for software as a service (SaaS) or on-demand applications, especially in the current

21 cfr part 11 compliant   Read More
The Lexicon of CRM - Part 1: From A to I
C.R.M. itself is an acronym, standing for Customer Relationship Management. This is part one of three-part article to provide explanation and meaning for most

21 cfr part 11 compliant  crm software,analytical crm,business process reengineering,b2b leads,hosted acd,hosted ivr,hosted contact center,outsource call center,sales leads management,sales force crm,callcenter software,leads generation,call centers,virtual call center,crm programs Read More

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