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CFR in Medical News

Axela introduces software to support 21 CFR Part 11 Compliance for Regulated Environments

TORONTO, May 7 /PRNewswire/ - Axela Inc., is pleased to announce the release of a software package for the dotLab(R) System that provides technical controls to support compliance with 21 CFR Part 11 regulations. This new package will be of particular interest to those working in pharmaceutical, bi...

Veracord Delivers FDA Expertise with SyberWorks Latest Learning Management Solution

...ts. "Our partnership with Veracord allows SyberWorks to leverage Veracord's strength and expertise in risk mitigation, compliance, validation, 21 cfr Part 11 and other production standards at work in regulated environments as we provide Learning Management technology to the Life Science, Medical Dev...

CSC's FirstDoc Recognized by EMC as a Preferred Regulatory Compliance Application for Life Sciences Industry

...increased regulatory scrutiny and quality procedures. Specifically, it helps companies meet Part 11 of Title 21 of the Code of Federal Regulations (21 cfr Part 11) to ensure that electronic records and signatures are equivalent to those based on traditional paper based methods. Earlier this year,...

Accuray Announces CyberKnife Access Remote Service Product

...itor the health and performance of their products from anywhere in the world, while helping them comply with industry regulations such as HIPAA and 21 cfr Part 11. About Axeda Axeda Corporation delivers secure remote service and support capabilities to some of the world's leading manu...

ERT Launches New Online Gateway to Improve Cardiac Safety in Clinical Trials

...nment to view and manage vital data, from anywhere in the world -- on demand, in real time. ERT's My Study Portal is the industry's only dedicated, 21 cfr Part 11-compliant, clinical trial portal. Julie Nelson, ERT's Director of Online Reporting Services, states, "We are very excited with the launc...

Lilly Receives Fourth FDA Approval for ALIMTA(R) (pemetrexed for injection)

...nt/CRI_2_4_1x_What_Is_Non-Small_Cell_Lung_Cancer.asp?sitearea= . Accessed May 1, 2009. (4) NOTE: The 2nd-line NSCLC indication was approved under 21 cfr 314.500 et seq (Subpart H - Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses) using a surrogate endpoint. (5) American Ca...

Innoventz Certified to Score Both the SF-36v2 and SF-12v2 Health Surveys

...al, while still taking advantage of all features in Oracle Clinical, an industry-leading clinical data management system (CDMS). Oracle Clinical is 21 cfr Part 11 compliant, meaning that it meets the FDA's guidelines regarding electronic records and signatures. Surveys are scored in real time utilizing Q...

SAFE-BioPharma Webinar Featuring ARX's Digital Signatures Combined with Microsoft SharePoint for Bio-Pharma industry

...ARX's CoSign® digital signature solution and enhanced by Nextdocs document management solution, enables approval automation as well as SAFE and 21 cfr Part 11 compliance. San Francisco, CA(PRWEB) June 4, 2009 -- On June 11 at 2pm (EST), SAFE-BioPharma, together with ARX Inc...

Niutang Sucralose Patent Litigation Successfully Concluded

... built upon the highest standards of quality control, with products that are: Manufactured according to cGMP requirements as stated in cfr 21 Part 110 Produced to meet all quality specifications required by current FCC Moody International ISO 9001:2000/cGMP/HACCP certified...

Swine flu: Early findings about pandemic potential reported in new study

... infected with influenza A (H1N1) in Mexico means that the case fatality ratio (CFR) of 0.4% (4 deaths per 1000) cannot be definitely established. The cfr is in the range of 0.3% to 1.5%, but at this stage the researchers believe that 0.4% is the most likely. For every person infected, it is likely tha...
CFR in Medical Technology

Qualia Clinical Services Chooses ALPHADAS(R) for Phase I Clinical Trials

...S sets the standard in collecting early Phase clinical trial data. ALPHADAS is fully compliant with industry standards and guidelines including FDA 21 cfr Part 11. More information about Logos Technologies can be obtained through its website at http://www.logostechnologies.com For more information co...

Trius Antibiotics to be Highlighted in 18 Presentations at ICAAC/IDSA

...Antibiotic -- F1-2065: In Vitro and In Vivo Efficacy of TR-701 and TR-700 Versus the Linezolid- and Methicillin-Resistant Staphylococcus aureus cfr Strain CM/05 -- F1-2066: Demonstration of TR-701 Efficacy in a Mouse Inhalation Anthrax Model -- F1-2067: Absence of a Pressor Response ...

Imaging Diagnostic Systems Updates PMA Filing Status for the New CT Laser Breast Imaging System

...nical study is a non- significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 cfr 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States. For more information, visit our webs...

Optimizing Quality Control Data Management

...Scandinavian Journal of Clinical & Laboratory Investigation, Vol. 59, No. 7, November 1999, 491-500 (an update is available at www.westgard.com) 42 cfr (Code of Federal Regulations), Ch. IV (10-1-01 Edition), Part 493 Westgard James O, Basic Planning for Quality, Westgard QC, Inc., 2000 Westgard...
CFR in Medical Products

21 CFR Pharma

Description: The pharmaceutical subset of the authoritative 2005 edition of Title 21 of the Code of Federal Regulations (CFR) with proposals and final rules published in the Federal Register. Content is updated regularly as released by the Government Printing Office. Need-to-know regulatory information on human...
Company:Unbound Medicine, Inc.

Flu A/B ASR

Description:...established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 cfr part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

mecA ASR

Description:...established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 cfr part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

Mycoplasma pneumoniae ASR

Description:...established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 cfr part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

RSV ASR

Description:...established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 cfr part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

Staphylococcus aureus (SPA) ASR

Description:...established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 cfr part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

Parvovirus (Erythrovirus) B-19 ASR

Description:...established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 cfr part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

Enterovirus ASR

Description:...established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 cfr part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

HSV Typing ASR

Description:...established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 cfr part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

Bordetella pertussis ASR

Description:...established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 cfr part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid
CFR in Biological Technology

Beta Release of v3.0 of OpenClinica Clinical Trials Software

...rials. OpenClinica supports leading CDISC standards and is designed to be compliant with industry and government regulations and guidelines such as 21 cfr Part 11, GCP, and HIPAA. OpenClinica is professionally supported by Akaza Research and has a worldwide open source community of over 6,000 users and d...

Gyros Raises SEK 80 Million to Accelerate the Commercialization of its Gyrolab(R) Systems for the Cost-Efficient Development of Biopharmaceuticals

...ry demands on testing. Several validated assays are already in some phase of clinical sample analysis. Gyrolab xP complies with the requirements of 21 cfr Part 11 and comprehensive validation support is provided. The company has over 50 employees based at its headquarters in Uppsala, Sweden and at...

ForteBio Launches Two Revolutionary High-Throughput, Label-Free Instruments: The Octet(R) RED384 and the Octet QK384

... include hardware and software robotic integration capabilities that support automation and database connectivity and can be licensed with optional 21 cfr Part 11 compliance tools. ForteBio's Octet biosensors are disposable and are configured in a standard microplate format. Its biosensors simplify ...

Precision Stability Storage Announces Upcoming Expansion

...validated to meet strict temperature, humidity and uniformity requirements. Stability rooms and chambers that are monitored 24 hours a day with 21 cfr Part 11 compliant systems and are connected to automatic emergency generator power to ensure integrity of stored samples. Back up conditioner and ...

Springborn Deploys eStudy(TM) Hosted Solution for Management of Global Environmental Testing

...ces, multiple users and multiple locations, integration of data in real-time to a secure storage device, maintaining data integrity (complying with 21 cfr Part 11) with the flexibility of on-demand access, data analysis and reporting that is user-defined and user-controlled. iAdvantage places control in ...

Akaza Research to Present and Exhibit at Upcoming DIA Annual Meeting

...rials. OpenClinica supports leading CDISC standards and is designed to be compliant with industry and government regulations and guidelines such as 21 cfr Part 11, GCP, and HIPAA. OpenClinica is professionally supported by Akaza Research and has a worldwide open source community of over 6,000 users and d...

Akaza Research to Present OpenClinica at ACRP Global Conference & Exhibition

...iguration, data collection via electronic case report forms (eCRFs), and enables productive clinical trials management. OpenClinica supports HIPAA, 21 cfr Part 11, and other regulator guidelines and is designed as a lightweight, standards-based, extensible, and modular platform. All versions of OpenClini...

U.S. Distributor Debut for PAKSCAN - a Pouch & Sachet Leak Tester Machine from Ireland-based Sepha Ltd.

...integrated system with internally generated vacuum. The system can be calibrated to National Standards. User access and data storage is designed to be cfr 21 Part 11 compliant. Aubrey Sayers, who is Chief Executive Officer of Sepha Ltd, explained: "U.S. customers have responded extremely well to...

AlloSource Distributes Record Amount of Tissue in 2008

...ion. Raising the bar for a more rigorous processing environment and quality control system by registering with the FDA as a Medical Device (21 cfr Part 820) Establishment. Reinvesting close to 45 percent of revenues with Organ Procurement Organization recovery agencies. These funds were ...

Polymer Science Releases New Silicone Gel Adhesive Products for MD&M West

...ariety of substrates and backings. Polymer Science manufactures products in controlled environments, has a documented quality system compliant with 21 cfr 820, is registered with the FDA as a medical device manufacturer, and is certified to the current ISO 9000:2008 standard to ensure that a consistent q...
CFR in Biological Products

N5 Submicron Particle Size Analyzer - 230V from Beckman Coulter

Description:...friendly Microsoft Windows-based software • Multi-angle analyses • High reproducibility • Small quantities of sample required • 21 cfr Part 11 compliance • 25 mW laser ...
Company:Beckman Coulter

Infinite F200 from Tecan

Description:...ir own application. Furthermore, optional Magellan software packages provide full data reduction capability and are designed to meet FDA regulation 21 cfr Part 11. Infinite F200 product highlights include: Modular concept allowing for later upgrades. Injector system for triggering of fast kinetic...
Company:Tecan

Guava EasyCyte from Guava Technologies

Description:...iple microplates. This is ideal for secondary screening labs that want to easily profile lead compounds and save on human resource costs. Supports 21 cfr Part 11 Compliance The Guava EasyCyte System software allows a laboratory administrator to restrict users from access to certain features in order to...
Company:Guava Technologies

Infinite M200 from Tecan

Description:...ir own application. Furthermore, optional Magellan software packages provide full data reduction capability and are designed to meet FDA regulation 21 cfr Part 11. Infinite M200 product highlights include: Modular concept allowing for later upgrades. Injector system for triggering of fast kinetic...
Company:Tecan

EZChrom Elite from JASCO

Description:... 21 cfr part 11, Compliant software for JASCO HPLC systems. Integrated Instrum...ational privileges, and electronic signatures and signoffs to handle the 21 cfr Part 11 requirements are justsome of the special features in EZChrom Elite...
Company:JASCO

Freedom EVOware from Tecan

Description:...up to multi-microplate scheduled runs on a fully configured Freedom EVO 200. Freedom EVOware is also ideal for laboratories working under the FDA 21 cfr part 11 regulation needing multilevel user management, full audit trail, electronic records and electronic signatures. Freedom EVOware highlights i...
Company:Tecan

Prelude Workstation from Caliper Life Sciences

Description:...nsfer, mixing and dilutions. Capabilities also include on-line HPLC, and UV detection. The Prelude performs these functions in full compliance with 21 cfr Part 11. The Prelude performs quantitative sample preparation on pharmaceutical samples such as bulk drugs, cleaning swabs, liquids, and semisolids. ...
Company:Caliper Life Sciences

SkanIt Software for Varioskan, Drug Discovery Edition from Thermo Scientific

Description:...a Research Edition for scientists working in life science research, and a Drug Discovery Edition offering features needed for compliance with FDA's 21 cfr Part 11, for the drug discovery industry....
Company:Thermo Scientific

Varioskan with one dispenser (100-240 V) from Thermo Scientific

Description:...ssays. The SkanIt Software's extreme usability and visual workflow makes any assay design easy. The SkanIt Software also offers features needed for 21 cfr Part 11 compliance....
Company:Thermo Scientific

Varioskan (100-240 V) from Thermo Scientific

Description:...ssays. The SkanIt Software's extreme usability and visual workflow makes any assay design easy. The SkanIt Software also offers features needed for 21 cfr Part 11 compliance....
Company:Thermo Scientific
CFR in Biological Dictionary

FIFRA

...ticite Act ... FIFRA is the primary federal authority for regulating the manufacture, ... ( FIFRA §136a(a) ... FIFRA regulations appear in 40 cfr 152–180. Under FIFRA , all ... FIFRA also mandates practices for management of waste pesticides and container residues. ... Federal Insecticide...
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