Davis Calibration Davis Calibration is a worldwide leader in the calibration, repair and certification of Test, Measurement and Control Instruments. Through decades of experience in the instrumentation field, we have developed innovative...
Finesse LLC Process Measurement and Control Solutions
Finesse was founded to bring digital, plug-and-play solutions to life science customers, so as to improve the management of complex bio-process applications. Our initial focus is...
Werum Software & Systems America, Inc. Werum Software & Systems is the worldwide leading supplier of Manufacturing Execution Systems (MES) for the pharmaceutical and biopharmaceutical industries.In December 2000, Werum founded Werum America, Inc. in...
Zumatrix Inc. Zumatrix is a leading supplier of truly configurable Laboratory Information Management Systems (LIMS).We implement highly productive systems on schedule and on budget for analytical and physical testing, microbiological,...
Indysoft We’re about to make your workplace the most efficient it has ever been…
IndySoft software products afford you the benefit of utilizing years of feedback and pooled resources from other industry-leading professionals in...
Prime Technologies Prime Technologies’ ProCalV5 Calibration Software solution drastically improves efficiency for any organization that are geared toward tackling a myriad of issues from compliance to quality, while still being pressured to...
Mediware Information Systems Mediware is a specialist provider of information systems focused on complex areas of healthcare. Through our more than 25 years of experience, our focus has evolved from departmental systems residing in pharmacies and...
iLAB, an acronym for “integrated laboratory”, is a term that describes a new type of laboratory informatics system - a total laboratory automation system.
Understanding the value of an iLAB starts with an understanding of 4 key problems with today’s informatics systems.
1. No ‘Real-Time’ Control of Users: On a daily basis analysts are required to follow SOPs, but there is no way to enforce the ...
The purpose of this study was to validate sensitive and specific Inductively Coupled Plasma-Atomic Emission Spectrometry (ICP-AES) methods to determine total cisplatin and carboplatin (as platinum equivalents) in human plasma samples. The method was independently validated for both compounds.
Guidelines for Assessment of Clinical Trial Software Integration Capabilities White Paper | September 2006
Guidelines for Assessment of Clinical Trial Software Integration Capabilities
Moving Beyond Compliance: Reinvention of Enterprise Risk Management
Today’s companies are facing significant chal- lenges in balancing all the regulatory pressures coming from a long list of regulatory agencies from corporate and financial such as SEC, DOJ, CBP, ICE, BIS and OFAC, to operational and product areas such as the FDA, EMA, EPA, ISO and more. Many of these programs are still ...
The right software can simplify and strengthen your quality practices.
W Whether your quality practices are guided by the technician of an unacceptable result. Subtle performance need for compliance with the Food and Drug variations can directly impact product quality. Administration (FDA), International Organization Regardless of what your company produces — food, bev- for Standardization (ISO) ...
Calibration, maintenance and validation activity, despite operating within the same department in some organizations, have generally been managed separately, each with their own procedures and their own computerized management systems. Since even calibration and maintenance professionals tend to access records differently and track different types of information, these separate and unconnected ...
The purpose of this white paper is to document and summarize the current status of the regulatory requirements set forth by different agencies like FDA (in US), ICH (in Europe), and that of Japan and China. In the first section of the paper we will provide the background information on the role of FDA, the regulatory agency in the USA, and the current state of cGMP “risk based approach” enforced ...
It's hard to find a vendor who is not touting the integration capabilities of their clinical trial applications. Evaluators of clinical trial offerings generally recognize the importance, and usually at least check to see that the “integration” word appears somewhere in the vendor's sales material. However, integration capabilities differ significantly among clinical trial software vendors, with ...
The MICROLAB® NIMBUS is Hamilton Company's newest automated multi-channel pipetting platform, offering a high density deck layout in a body small enough ...
Carestream is pleased to announce the release of our newest accessory for our advanced MI Software. With this powerful new addition, you can now perform ...
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