Quality Management Overview
A Quality Management System is a way of ensuring all processes in your organization are performed with a high standard of quality. Why is this important? High quality standards affect your end product at any stage in the research process. Knowing that you can rely on each step in the process helps to ensure you are producing the most valuable data to move onto the next stage.
ABS helps researchers to achieve quality products and services through strict adherence to processes which are guided by Standard Operating Procedures (SOPs). These SOPs are regularly reviewed and audited for conformance.
Advantages of a Quality Management System
Drug discovery and other research relies on a regulated system that requires researchers to follow guidelines, procedures, and documented evidence of the research. A Quality Management System can set you up with the right documentation when audits are performed, or questions are asked internally.
Even early stage research can benefit from a Quality Management System. A well thought out system for tracking and reporting data makes it easier to understand research results and can affect patentability. At a more granular level, standardization of assays makes data more consistent and reproducible. For example, even simple protein measurements can vary significantly depending upon the assay used, how rigorously is it performed, and the protein standard used. Standardization removes ambiguity and can improve data quality.
From the time of our first contact with you, our processes are in place to make sure the details of your research issues are captured and communicated to the laboratory to find the right solution for you. Our Quality Management System also ensures that our clients are informed every step of the way throughout the discovery and solution process.
A Quality Management System, when implemented can benefit your research in many ways. From standard procedures to documentation and best practices record keeping, your research can be viewed as higher quality than others without a Quality Management System.
Strategic and Risk Based Thinking
A Quality Management System can provide you with insights on how to align your strategic vision while making sure to remain vigilant on possible risks that affect your business and your research. Through regular discussions about improvements, corrective actions, trend analysis, and change management, top managers can make difficult decisions to achieve your company’s main objectives.
The company’s goals and objectives will be more easily achieved when everyone is working towards the same vision. All employees remain directly involved in the operation and improvement of the Quality Management System. It is a way to build stronger teams to provide greater purpose.
Best Practices for Quality in Research
Your painstaking efforts to get your projects completed are best achieved using a Quality Management System. Your organizations’ best practices may include any of the following and more.
- Observance of Federal Regulations
- Observance of Institutional Regulations
- Observance of Safety Regulations
- Roles and Responsibilities of the Principal Investigator
- Roles and Responsibilities of other research team members
- Verification of IRB consent
- Verification of IRB protocols
- Collaboration with External Interested Parties
- Effective Documentation of Changes Assay Standardization
- Data Entry and Reporting
Each of these areas can be easily incorporated into one Quality Management System to help you achieve your intended results. ABS regularly evaluates our Quality Management System to ensure that our clients can meet their research goals. We are happy to share with you our experiences and insights.
VLADISLAV GOLUBKOV, PH.D.
Research & Business Development Director, ABS Bio
30+ years in life sciences
Biotechnology expert
45+ peer-reviewed publications
Vladislav Golubkov, Ph.D., is Research & Business Development Director at ABS Bio. He is a biotechnology expert with over 30 years of industry and academic experience in biospecimen solutions, biobanking, cell and molecular biology, and translational research. Dr. Golubkov specializes in the commercialization of custom biospecimen and research services, partnering with pharmaceutical and biotechnology companies to deliver high-quality, fit-for-purpose solutions for drug discovery and clinical development across diverse therapeutic areas. He has extensive experience aligning scientific operations with client and market needs to drive revenue growth and long-term partnerships.
Prior to his current role, Dr. Golubkov held scientific and leadership positions at the University of Southern California (USC), Sanford Burnham Prebys Medical Discovery Institute, and Cureline Inc.
He is a published author of over 45 peer-reviewed articles and a former NIH-funded principal investigator.
