In the United States, the Food and Drug Administration (FDA) has a number of guidances that are meant to st...
Ever since the Precision Medicine Initiative was announced in 2015, personalized medicine has taken off. Mapping the human genome, 3D printing, artificial intelligence and advanced scanning technology
This publication provides an in-depth look at the FDA’s transformation and addresses how the agency’s initiative will impact manufacturers of regulated products.
Knowledge of regulatory requirements and the application of rigorous clinical investigation processes can help companies accelerate the time it takes to bring new devices to the market.
Fagron is an international personalized medicine pharmaceutical company that recently started using MasterControl to improve its quality and manufacturing processes.
MasterControl’s clinical management system allows management at every phase of a clinical trial from a single platform.
Learn about MasterControl's eTMF product and how it can help your business. Learn more about eTMF Software Systems and more: https://www.mastercontrol.com/clinical/etmf-software-systems/
See how MasterControl’s eTMF Manager software solution enables real-time visibility into the status of all clinical study activities and trial master file artifacts.
Efficiently manage all clinical study information, including Trial Master Files (TMF) and data from participating study sites and clinical vendors supporting a study.
MasterControl Clinical Excellence™ offers a comprehensive clinical quality management system (CQMS) that handles every component of clinical trials, including CAPA management.
MasterControl Clinical Quality Management System (CQMS) provides you with the tools you need to manage quality and operations before, during and after your clinical trial.
Managing all the artifacts in a trial master file (TMF) can be a daunting task. Instead of relying on paper, use the MasterControl eTMF Management System to digitize the whole process.
Managing vendors is difficult when vendor information is on different systems that don’t communicate with each other. MasterControl Clinical Supplier Management Software eliminates those problems.
Using the MasterControl Clinical Audit Management System connects training, site, study and vendor management on the same platform.
In this video, Linda Chatwin, Esq., RAC from UL explains how to prepare for the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR).
MasterControl customer Contract Pharmacal Corporation used to be a paper-based organization. They’ve greatly benefited from switching to MasterControl’s electronic quality management system (QMS).
This white paper examines the key points of the guidance and the thinking behind the FDA’s 2009 “Guidance for Clinical Investigators, Sponsors and IRBs”
This white paper discusses common audit-related challenges faced by non-clinical research laboratories that still use a paper-based quality system.
The College of American Pathologists (CAP) outlines the requirements and benefits of CAP accreditation for clinical laboratories.