Latest GxP Stories

Quality Integrators Corporation, QIC, will be on hand with Lighthouse Systems to present Shopfloor-Online, Lighthouse Systems’ flagship MES software, at the Food Safety Summit Expo and Conference at the Baltimore Convention Center. Shopfloor-Online provides a real-time view of all aspects of Manufacturing Operations Management. Rochester, NY (PRWEB) April 24, 2013 QIC, together with Lighthouse Systems, are set to present Shopfloor-Online, Lighthouse Systems’ MES Software on booth...

Appointment also further strengthens growing Pharmacovigilance practice KAISERSLAUTERN, Germany, April 15, 2013 /PRNewswire/ -- pharma solutions international GmbH (pharmaSOL) announced today the appointment of Dr. Marc A. Zittartz to the position of Chief Strategy Officer, starting June 1st, 2013. In this role, he will be responsible for developing and implementing pharmaSOL's strategy to deliver innovative technology solutions, GxP compliant cloud hosting and expert consulting...

WOBURN, Mass., Jan. 23, 2013 /PRNewswire/ -- IVT Network, the most trusted resource for validation and compliance professionals in FDA-regulated industries was officially launched today www.ivtnetwork.com. IVT Network provides unmatched regulatory and industry guidance. Members access peer-reviewed journals and archives, training videos, protocols and SOPs, conference compendiums and a variety of other information products. The creator of IVT Network, The Institute of Validation...

MERIDEN, Conn., Oct. 24, 2012 /PRNewswire/ -- Protein Sciences announced that Tim Fields, Vice President of Quality, was named recipient of the Ken Chapman Industry Recognition Award during the International Validation Week Conference presented by the Institute of Validation Technology (IVT) on Oct. 23, 2012. Ken Chapman who died of pancreatic cancer in 2006 was renowned for his forward-thinking approach to regulatory issues and best practices. Many of his ideas have become...

During this 5 day audit, the FDA thoroughly inspected Intrinsic Imaging’s entire quality management system (QMS) and all clinical trial data. Intrinsic Imaging was found to be in complete compliance with all federal regulations and received zero 483 observations from the FDA. Boston (PRWEB) August 07, 2012 Intrinsic Imaging, an FDA audited, ISO 9001:2008 certified and GAMP® 5 compliant contract research organization providing medical imaging core lab services for clinical trials,...

IRVINE, Calif., April 25, 2012 /PRNewswire/ -- AtheroNova Inc. (OTCBB: AHRO), a biotech company focused on the research and development of compounds to regress atherosclerotic plaque, today announced that it has signed an agreement with Frontage Laboratories, Inc. to commence work on the formulation, compounding and tabletization of the Company's AHRO-001 product in advance of the upcoming Phase I human clinical studies. Frontage, based in Exton, Pennsylvania, is one of the leading...

SAN FRANCISCO, Jan. 11, 2012 /PRNewswire/ -- goBalto, developer of new generation web-based clinical research solutions, announced that it successfully completed a FDA 21 CFR Part 11 compliance audit of its goBalto Tracker(TM) Software-as-a-Service (SaaS) clinical trials application. Tracker's successful audit will help both sponsors / clinical research organizations and investigator sites running clinical trials comply with FDA rules and regulations governing electronic records and...

CARY, N.C., April 26, 2011 /PRNewswire/ -- Cetero Research, the leading early-stage contract research organization (CRO), today announced the appointment of James "Jay" Dixon to Senior Vice President, Quality and Compliance. Dixon has spent more than 25 years in the pharmaceutical, biotechnology and CRO industries, and will bring his extensive experience to support Cetero's objective of maintaining its market leadership position. (Photo: http://photos.prnewswire.com/prnh/20110426/PH89541...

LONDON, May 14 /PRNewswire-FirstCall/ -- Grandstream Networks, a globally recognized manufacturer of high quality and affordable IP PBXs, SIP trunking gateways and IP voice and video solutions for the worldwide VoIP SMB market, is pleased to announce full interoperability with Voipswitch a recognized leader in softswitch communication globally. The Grandstream IP PBX offers advanced functionality, ease-of-use and affordability as an all-in-one IP PBX solution. Grandstream's IP PBX...