BioIVT, a provider of research models and services for drug and diagnostic development, will use this International Organization for Standardization (ISO) compliant quality management system (QMS) – Master Control – to manage documentation, auditing, supplier and customer accounts, and risk.
The QMS will consolidate and replace computer- and paper-based document control systems used throughout existing and newly-acquired BioIVT sites in the US, Europe, and Asia.
Courtney Noah, VP of marketing at BioIVT, told us the company saw the opportunity of using the QMS as a tool to further emphasize its commitment to quality processes, as well as a way to provide trial transparency through procedures across its sites.
Noah explained, “It was critical that we invest in a high-caliber enterprise quality management system to support our infrastructure. Implementation of the MasterControl platform will allow us to digitize, automate and integrate our quality and compliance processes across all BioIVT locations.”
Since August 2017, the company has acquired five companies including Asterand Bioscience, Qualyst Transporter Solutions, Optivia Biotechnology, Ascendance Biotechnology, and Clinical Trials Laboratory Services.
“As we acquired each entity, it was clear that we needed a universal quality system to standardize processes at all sites,” said Noah.
Master Control will provide oversight of the company's quality management and training programs. As part of its management capabilities it will assign training automatically when documents relevant to a project are entered into the system.