Why Biotechs Need a Quality Management System
“We are committed to helping virtual biotechnology companies navigate the sometimes complicated waters of Quality Management. Our software will help them more easily meet the FDA requirements for quality and document management” said Dr. Richard Soltero, President of InstantGMP™.
CARY, N.C. (PRWEB)
May 19, 2020
InstantQMS™ is a complete Quality Management System that is fully integrated with a complete set of Standard Operating Procedures that work together with processes and logs for incidents, customer complaints, CAPAs, change control, vendor management and document management. Guided workflows and autonomous operations coupled with a Learning Management System make this the fastest way to get started in managing quality for a company in the preclinical to early clinical stages of development.
According to the FDA, a sponsor is the individual or entity that is responsible for the oversight of the clinical trial and for all communications with the FDA. In practice, this means that the sponsor, virtual biotech, must establish a quality system and negotiate vendor agreements with vendors and contractors, approve all clinical materials, maintain controlled documents and ensure vendors and contractors are qualified.
InstantQMS, through its easy-to-use interface and web-based system, allows the sponsor to maintain and monitor all records related to their drug product, virtually. The sponsor can keep control of quality, minimize potential problems in clinical trials and manufacturing, improve investor confidence and reduce risk with minimum executive oversight. With the optional Learning Management System, training is autonomous and allows training to be done on-line with pre-defined curricula that can include quizzes and certificates. The user’s Training Log is then automatically updated. No need for time-consuming training of virtual manufacturing partners!
InstantQMS was developed by a team of experts in quality, regulatory affairs and FDA project management at InstantGMP, Inc.
About InstantGMP, Inc.
Founded by pharmaceutical industry veteran Richard Soltero, InstantGMP, Inc., offers affordable all-in-one manufacturing and quality software. The company develops cloud-based electronic batch record software and standard operating procedures specific to industries that are required to follow FDA manufacturing regulations and Good Manufacturing Practices (“GMP”). As a manufacturing software company, InstantGMP pioneered accessible, easy-to-use electronic batch record software for products manufactured using GMPs. The Company’s updated software simplifies the documentation and approval procedures for quality processes that keep all quality documentation organized in electronic format while providing for quality checks and workflow processes to make compliance with FDA requirements easy.
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