EQMS Implementation: Pick the Right Person and System for the Job
Implementation - 15 July 2015
We have all heard the analogy of building a house, and the inherent importance of a good foundation—and how this might apply to the management of a company or a department. Equally important are the systems (electricity, water, heating, etc.) being installed in the house featured in this analogy. The other thing that is not frequently discussed when the analogy is used is: who is building and installing the systems in the house?
You should always endeavor to hire an experienced specialist for each system being installed in your proverbial house, such as a licensed electrician and plumber. And this should go without saying: do not hire your brother-in law, and pay him with a case of beer, to install your systems on the weekend!
By extension, the same applies when selecting and installing/integrating Enterprise Quality Management Software (EQMS) for your company. Choose a company that has direct experience with your industry and business model. The life-sciences industry is a highly-regulated one, and it is imperative that you know beyond a shadow of a doubt that the system will meet all regulatory requirements and will withstand the scrutiny and rigor of a regulatory inspection.
Select an EQMS system that can grow with you, and that has the potential to scale! Implement the quality applications that will give you the most benefit, improving operations and reducing risk first. The transition from paper-based systems to an electronic system can be challenging and even intimidating. Don’t take on too much change all at once! Pace yourself, don’t bite off more than you can chew, and get some early wins and support for the system, by phasing the implementation of the EQMS over several months.
The business models that companies use may vary from fully integrated, virtual, contract manufacturer, contract packager, contract laboratory or hybrid. The quality system needs are different for each company type. Besides the business model, other factors such as the number of products, types of products, number of sites, manufacturing complexity, organizational size, number of markets and current regulatory compliance status will affect the design and implementation priorities for the EQMS. Choose a company that understands the life-sciences industry, can understand your business and help you make the transition to an EQMS.
About the Author
Brian Graeff is currently the Head of the Quality Best Practices Unit at SOLABS. Brian’s career in the pharmaceutical industry spans over 40 years during which he held various management positions in Quality Assurance, Quality Control and Production with Sterling Drug-Winthrop Laboratories, AstraZeneca and Sunovion Pharmaceuticals Inc.. Brian retired from Sunovion in 2010, where he served as the VP of Quality Operations. During his career, Brian helped manage many different drug products and API’s with the majority of his experience being with parenteral, respiratory and tablet dosage forms. Brian brings a wealth of experience in pharmaceutical manufacturing, quality management, FDA interactions and CGMP interpretation and implementation to the table.