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34 software items found
by:RegScan - by Enhesa based inWilliamsport, PENNSYLVANIA (USA)
The medical device reporting (MDR) requirements of 21 CFR 803 apply to manufacturers, importers, distributers, and device user facilities in the United States. Such facilities are required to report adverse device-related events to the Food and Drug Administration (FDA) or the device manufacturer, and occasionally to both. These requirements are supplemental to ...
by:Simplified Software based inSanta Cruz, CALIFORNIA (USA)
Beginning in 2008, an industry-led effort to enhance produce traceability throughout the entire produce supply chain was launched as the Produce Traceability Initiative. The U.S. Food and Drug Administration noted in 2007 that fruit and vegetable-related outbreaks of food poisoning are on the rise and had struck in spinach, tomatoes, lettuce and cantaloupes. The ...
by:Freyr Solutions based inPrinceton, NEW JERSEY (USA)
Structured Product Labeling (SPL) & Structure Product Monogram (SPM) is the mandatory document markup standard for Regulatory submission of label content, product and facility information, and any subsequent changes to an existing label information in an electronic format. SPL-SPM format defines the structure and content of label information as required by the United States Food and ...
by:MasterControl, Inc based inSalt Lake City, UTAH (USA)
Each manufactured medical device must be supported by appropriate documentation which demonstrates that its development followed the Food and Drug Administration's (FDA) design control guidelines. MasterControl offers design control software systems for the design history files (DHF) which are established for each device to house this documentation for the ...
Manufactured by:Stilla Technologies based inVillejuif, FRANCE
Electronic documentation offers many benefits, including increased efficiency and productivity when storing data and easier information sharing and data mining. The Food and Drug Administration (FDA) of the United States (USA) regulates the food and drug industry of the USA with the Code of Federal Regulations (CFR). The FDA is within the ...
by:Certara based inPrinceton, NEW JERSEY (USA)
It is the industry standard for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and toxicokinetic (TK) modeling with a proven 30-year history. Regulatory agencies, including the US FDA, Japan Pharmaceutical and Medical Device Agency (PMDA), China Food and Drug Administration (CFDA), and the UK Medicines and Healthcare Products ...
Manufactured by:Marathon Products, Inc. based inSan Leandro, CALIFORNIA (USA)
Our database has been designed for the biotech, medical, and pharmaceutical industries and complies with the Food and Drug Administration’s Code of Federal Regulations Section 21 CFR Part 11, which is germane to electronic record-keeping. Marathon 21 CFR DB validates data and works seamlessly with Marathon’s intelligent data collection devices. Our ...
Manufactured by:Bioreactors.net based inRiga, LATVIA
The user interface acts through SCADA. BioRe is develop according the requirements of 21 CFR Part 11 (document from US Food and Drugs Administration). Thet means that the process can be evaluated, reviewd, approved and archived without a single sheet of paper and without the possibility to falsify process data and signatures. Software development is based on ARC ...
by:AWS Truepower, LLC based inAlbany, NEW YORK (USA)
Medical technology advances quickly, and with it the need for compliance systems to support patient safety. To help you and your workforce stay up to date with the latest U.S. Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) training, HIPAAA training, ISO 14971 training and more, we created ComplianceWire®. ...
Manufactured by:OTT HydroMet - Veralto based inKempten, GERMANY
A specialist in its field: MCPS8 is compliant with 21 CFR Part 11. The Lufft OPUS20 datalogger series includes the SmartGraph3 software in delivery. If you require a larger range of functions for a special application of the OPUS20 series, you can additionally use the MCPS8 software from CAD-Computer & Co.KG covering a wide range of functions: From configuration, data storage and transmission ...
by:Simulations Plus based inLancaster, CALIFORNIA (USA)
GastroPlus is a simulation software designed for detailed mechanistic modeling of drug absorption across various administration routes including intravenous, oral, ocular, inhalation, dermal, subcutaneous, and intramuscular delivery. It is utilized to simulate the pharmacokinetics and pharmacodynamics properties in both humans and animals. The platform integrates ...
by:Freyr Solutions based inPrinceton, NEW JERSEY (USA)
Freyr rDMS is an end-to-end electronic Regulatory Document Management System (rDMS/eDMS) exclusively designed to enable Regulatory groups and departments within a life sciences organization to seamlessly create, capture, manage, organize, connect, deliver and archive Regulatory data and documents in a compliant, efficient and intuitive ...
Manufactured by:Finapres Medical Systems based inEnschede, NETHERLANDS
New GAT application enables standardization and quantification! In autonomic testing, standardized procedures are essential for reliable test results. Finapres Medical Systems developed a Guided Autonomic Testing (GAT) application as part of the Finapres® NOVA, which guides the operator and the patient through a series of autonomic test maneuvers. The GAT application consists of a graphical ...
by:STARLIMS Corporation based inHollywood, FLORIDA (USA)
SDMS acts as a central repository for all of your lab’s valuable document and data files. Our scientific data management solution makes it easy for users to access and share information across the ...
Manufactured by:Finapres Medical Systems based inEnschede, NETHERLANDS
New GAT application enables standardization and quantification! In autonomic testing, standardized procedures are essential for reliable test results. Finapres Medical Systems developed a Guided Autonomic Testing (GAT) application as part of the Finapres® NOVA, which guides the operator and the patient through a series of autonomic test ...
by:Certara based inPrinceton, NEW JERSEY (USA)
The one software ecosystem to streamline your PK/PD data management and analysis; With all the tools you need in a single, interoperable platform, effortlessly share pre-clinical and clinical knowledge across your organization through secure and consistent workflows using Phoenix-based tools and 3rd-party applications. Phoenix WinNonlin is the first choice for non-compartmental analysis (NCA), ...
by:Analyse-it Software, Ltd. based inLeeds, UNITED KINGDOM
Combining all the Analyse-it statistical analysis, method validation, and statistical process control tools in a single ...
by:Qualityze Inc based inTampa, FLORIDA (USA)
It is easy to confuse the definition of Compliance and Quality as they complement each other. Compliance is about being compliant with specification, policy, standard or law. Also, regulatory compliance for an organization describes the goal to achieve in their efforts to display that they are in conformity with the established regulations, guidelines or specification and government legislation. ...
by:Analyse-it Software, Ltd. based inLeeds, UNITED KINGDOM
Validate and verify your analytical and diagnostic methods to meet the demands of regulatory ...
Manufactured by:3DHISTECH Ltd. based inBudapest, HUNGARY
ClinicalViewer is a digital microscopy application designed for supporting the histopathological diagnostic workflow and the microscope examination process. Thanks to the direct communication between CaseManager and ClinicalViewer, the pathologist can easily and quickly view digital microscopic images of the pathology case, helping to make an accurate ...