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- Meeting US FDA 21 CFR Part 11 Requirements
- The U.S. Food and Drug Administration FDA introduced 21 CFR Part 11 (Part 11) regulations to promote wide usage of electronic technology in the life sciences industry in a way that is compatible with FDA's responsibility to protect public health. MetricStream, the leading provider of compliance and...
- Tags: software, regulation, quality management, life science, compliance, public health, MetricStream Inc., food, FDA
- White papers
- Medical Products Maker Taps Opportunities With Complete, Accurate Customer Data
- In late 2002, Conceptus, a California-based medical products company, received approval from the U.S. Food and Drug Administration FDA to market its Essure product in the United States. Anticipating rapid growth, the company needed to improve its efficiency and streamline the tracking of physician training on the product. In 2003,...
- Tags: FDA, Mobile, Medical Product, Microsoft Corp., Microsoft CRM, Federal Government, Advertising & Promotion, Customer Relationship Management (CRM), Healthcare, Enterprise Software, Government, Marketing, Software
- Case studies
- Schering-Plough Moves to Paperless Calibration
- FDA's compliance imperatives and guidelines for calibration set by ISPE in the GAMP Good Practice Guide for Calibration Management demand that pharmaceutical manufacturers establish robust calibration systems. Schering-Plough (Kenilworth, N.J.) installed a paperless calibration system at a number of its manufacturing facilities. The system, Prime Technologies' (West Chester, Pa.) ProCalV5,...
- Tags: Calibration, FDA, Compliance, Schering-Plough Corp., ProCalV5
- Case studies
- Understanding the FDA and EMEA's New Labeling Standards: The SPL and PIM Technology Solution
- With the mandatory FDA Structured Product Labeling SPL and EMEA Product InforMation PIM compliance deadlines, life science companies are forced to look at new technologies to achieve their goals. This webinar will take a look at the business and technology needs that are needed to address SPL and PIM, while...
- Tags: FDA, Compliance, Standards, Federal Government, Government
- Webcasts
- Cisco Highlights IP Network Solutions for the Federal Government at FOSE 2006
- Physicians, nurses, consumer safety officers, lawyers, and scientists in multiple agencies within the U.S. Food and Drug Administration FDA regulate medical devices, transplanted tissues, cosmetics, blood transfusions, and even devices that emit radiant energy such as cell phones and microwave ovens. Each year the collective data pool managed by all...
- Tags: FDA, Agency, IP, Cisco Systems Inc., IP Network, Federal Government, Government
- Case studies
- Process Automation and Change Management for FDA Regulated Companies - Recommended Approaches and Tools for 21 CFR Part 11 Compliance
- Many life sciences and FDA regulated companies are finding it necessary to automate business processes in order to remain competitive. Those that take the time and care to do it right will reap the benefits of lower administration and a higher confidence in their regulatory readiness. Doing it right is...
- Tags: Process Automation, FDA, Compliance, Tool, MKS Inc., Federal Government, Change Management, Government, Tools & Techniques, Management
- Webcasts
- HyClone Uses Integrated Manufacturing Suite for Compliance With FDA Requirements
- Founded in 1967, HyClone has revolutionized the cell culture industry, evolving into a leader in manufacturing cell culture media, sera, and BioProcess Container systems. In April 1998, HyClone began preparing for Y2K, and took the opportunity to rethink its entire information system. Each of its sites was using separate PC-based...
- Tags: FDA, Compliance, HyClone, Manufacturing
- Case studies
- Product Lifecycle Management in the Medical Device Industry
- In the medical device industry, efficiently meeting U.S. Food and Drug Administration FDA requirements is a key to business success. Product Lifecycle Management PLM technology ensures FDA compliance integrity by providing comprehensive content to support management decisions across the organization and individual functional groups. By uniting product information with processes,...
- Tags: FDA, Product Lifecycle, Medical Device, Product Lifecycle Management, Product Lifecycle Management Technology, Product Marketing, Federal Government, Marketing, Government
- White papers 2008-01-01
- IT Governance and Controls for FDA & SOX compliance: The single solution
- If yours is an FDA regulated pharmaceutical manufacturing firm and you must comply with the Sarbanes-Oxley Act of 2002 SOX Section 404 controls for Information Technology IT, then a natural question to ask is: can you combine the IT Controls required for SOX with the measures needed to meet FDA...
- Tags: FDA, IT Governance, Sarbanes-Oxley Act, Information Technology, Compliance, Sarbanes-Oxley, Federal Government, Regulatory Compliance, Regulations, Strategy, Government, Financial Accounting, Finance, Human Resources, Policies And Procedures, Management
- Webcasts 2007-11-01
- Chromium Picolinate Fat Loss (exe)
- Chromium Picolinate is a nutritional supplement that works to increase the efficiency of insulin to optimal levels. This popular nutritional supplement is a combination of the element chromium and picolinic acid. FDA recommends a daily chromium intake of approximately 130 mcg, as small amounts of chromium are needed to aid...
- Tags: FDA, Supplement, Chromium Picolinate, Federal Government, Government
- Software downloads 2007-06-29
- Dog Food Recall (exe)
- Get the life saving information you need to know about the huge dog food recall. This Dog Food Recall software has vital information on the huge dog food recall of 2007 including: What Dog Foods Have Been Recalled? Which Dog Foods Are Safe? What Is The FDA (U.S. Food and...
- Tags: Food, FDA, Federal Government, Food & Beverage, Government, Manufacturing
- Software downloads 2007-05-10
- Cat Food Recall (exe)
- Get the life saving information you need to know about the huge cat food recall. This Cat Food Recall software has vital information on the huge cat food recall of 2007 including: What Cat Foods Have Been Recalled. Which Cat Foods Are Safe. What Is The FDA (U.S. Food and...
- Tags: FDA, Federal Government, Government
- Software downloads 2007-05-10
- PeopleSoft Enterprise Learning Management: Achieving FDA 21 CFR Part 11 Compliance
- PeopleSoft Enterprise Learning Management ELM 9.0 is the solution for organizations providing learning in a regulated industry. Organizations can use PeopleSoft ELM to meet specific 21 CFR Part 11 and predicate requirements, plus general corporate learning needs, with one robust, integrated solution. This whitepaper describes the need for compliance with...
- Tags: PeopleSoft Inc., FDA, Compliance, PeopleSoft Enterprise Learning Management 9.0, Federal Government, Government
- White papers 2007-03-01
- FDA Approves Viral Adulteration of Our Food Supply
- Please read the article:http://www.healthy.net/scr/news.asp?Id=8621Is this really necessary? I've been eating food for a couple of years now and haven't had too many problems with it.Pass the virus please.TerroristsNo. Listeria is one of those annoying bugs that continues to multiply even in the fridge. It's really quite widespread and, if you...
- Tags: edited out, FDA, food, HaveFun_Peace, ItsTheInThingToDo, NB_HaveFun_Peace, NeverBusted, No. Listeria, off-topic, Ol' NB, OnTheRopes, study author, tag shmag, your tax dollars at work
- Discussion threads 2006-09-15
- X.509 V3 Certificate - Help!
- I have been given the task of making sure that we my company can be in compliance with an agency policy. See the link below. Has anyone ever dealt with requesting certificates for multiple people/emails in their organization? I am not sure how to go about this. I have already...
- Tags: BreakFix, compliance, fda, digital certificate, x.509 v3, rfc 11, e-mail, agency
- Discussion threads 2006-08-09
- FDA Enables Secure Email Communications using Tumbleweed
- The U.S. Food and Drug Administration FDA Center for Drug Evaluation and Research CEDR needed a solution to enable e-mail communications between itself and various companies it regulates in the pharmaceutical and biotechnology industries. They were looking for a cost-sensitive practical approach that also incorporated the security they needed for...
- Tags: FDA, Tumbleweed Communications Corp., Federal Government, E-mail, Government, Online Communications
- Case studies 2004-12-01
- Data Management in Analyzing Clinic Trial Data - Metadata Application
- Efficiently handling Clinical Trial Data based on the Clinical Data Interchange Standards Consortium CDISC standard, the regulatory rules from U.S. Food and Drug Administration FDA and electronic data submission requirements is very important for Drug Development. Effectively managing Clinical Trial data can vastly increase work efficiency and reduce the probability...
- Tags: FDA, Clinical Trial, SAS Institute, Data Management, Federal Government, Healthcare, Government
- White papers 2004-04-14
- Electronic Signatures & FDA: Electronic Signatures and FDA's 21 CFR Part 11
- Biometric signatures, is not only similar to a handwritten signature but is also less intrusive than most other biometric authentication techniques, such as retinal eye scan, or fingerprint. The biometrics of a handwritten signature is based not only on the shape of the signature but also the dynamics of the...
- Tags: FDA, Signature, CIC, Federal Government, Biometrics, Government, Security
- White papers 2002-03-22
- Wireless interference in healthcare is real but manageable
- By Kenneth KleinbergElectromagnetic interference between electronic transmitting devices and medical equipment is a small but growing problem that healthcare organizations HCOs should not ignore. Although few facilities will be able to develop their own leading-edge expertise in detecting and reporting such problems, all HCOs should become familiar with and implement...
- Tags: EMI Group Plc., Gartner , health care, PDA, wireless, WLAN
- Technical articles 2003-04-21
Additional Resources
- Three Rivers Pharmaceuticals Saves 50 Percent of Its IT Budget With Oracle E-Business Suite On Demand
- Three Rivers Pharmaceuticals (3RP) is a privately owned pharmaceutical company that develops and markets generic prescription drugs. While still in its start-up phase, the company decided it wanted a technology infrastructure to help measure and track its compliance with complex FDA requirements. The technology solution it was looking for had...
- Tags: Oracle Corp., Information Technology, Oracle E-Business Suite, Pharmaceutical Company, Federal Government, Operational Accounting, Enterprise Software, Government, Finance, Software
- Case studies
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