Design & Development Case Studies & White Papers

1. Quality System Metrics That Matter 8/27/2021

   Product quality is a top priority in any business because nothing else matters without it. Measuring the impact of quality instantly becomes the No. 1 business imperative when those process inefficiencies begin to negatively affect the bottom line. See how these companies digitized and connected their document management processes to help accelerate the time it takes to get a product to market without jeopardizing regulatory compliance.

2. Metrics That Matter For Contract Manufacturing 8/27/2021

   For Contract Development, Manufacturing and Packaging organizations (CDMOs, CMOs and CPOs) improving operational flexibility, increasing capacity, shortening lead times and improving product quality is more important than ever as demand and competition for contract services increases. In these examples we show how moving from a paper to a digital solution these customers were able to eliminate data entry errors, reduce deviations, and improve overall efficiency and productivity.

3. Getting Executive Backing For A Digital QMS 8/26/2021

   As someone working in quality, you understand how vital your role is for improving efficiency, achieving quality, and meeting compliance. Your work is critical, and it’s essential to have the right tools do your job well – which means having a digital quality management system (QMS). Most executives cite the high cost of adopting technology as the main reason they reject plans to invest in digital systems. This article offers guidance that will help you quantify and communicate the importance of quality, and how a digital QMS delivers considerable savings.

4. 6 Must-Haves For A Quality Management System (QMS) 8/26/2021

   The best way to build quality into a product is with an effective, connected quality management system (QMS), which serves as the foundation for long-term regulatory compliance and market success. However, not every QMS has the same capabilities and connectivity. A QMS that isn’t connected to other areas of the enterprise still slows down quality processes and introduces the possibility of more human error. In this article we highlight six features of a QMS system that will help companies realize maximum value for years to come.

5. Automating Document Control Processes To Comply With FDA And ISO Requirements 8/25/2021

   Careful handling of the large amounts of documentation required for regulated products is critical for achieving compliance. Furthermore, document control guidelines enforced by the U.S. Food and Drug Administration (FDA) and the standards set by the International Organization for Standardization (ISO) continue to evolve. This means your document control system should be agile and scalable to keep up with the changing regulatory landscape. This article details the FDA guidelines and ISO standards that apply to document control, and it illustrates how digitizing document control processes is essential for ensuring ongoing compliance and future relevance.

6. Quality With Clarity: Bringing Modern Quality Systems Into Focus 8/24/2021

   Modern pharmaceutical regulatory and manufacturing models have made great advances assuring and confirming quality of products for all of us. Early in the process, industry responded by making a large-scale effort to develop and implement quality practices designed to assure or confirm product quality. The further industry moves from the initial application of the early practices and subsequent systems, the more challenging it has become to differentiate between the many facets of quality concepts. The intent of this white paper is to clarify those concepts and bring their fundamentals into focus.

7. What Is The True Cost Of Not Having An eQMS? 8/23/2021

   It is safe to assume that no organization that intends to stay in business sets out to manufacture or provide a low-quality product. This is particularly true for highly regulated companies. And yet switching from a manual quality management system (QMS) to an electronic one in order to improve product quality and ensure regulatory compliance remains low in most companies’ list of priorities. In this white paper we discuss the most common “quality pains” I’ve seen among regulated companies and offer some strategies on choosing and executing an eQMS.

8. Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products 8/4/2021

   As the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.

9. Manufacturing Process: Tools For A Successful Startup 3/11/2021

   Medbio offers a number of tips to follow for a successful startup in designing and producing injection-molded parts. 

10. Elements Of Design: Dealing With Suspect Parts 3/11/2021

    Injection molding has numerous key parameters that must tie together in order to make a repeatable molding process. Medbio offers a solution that utilizes cavity pressure curves, key process parameter tolerances, and automation to automatically reject parts that do not make the cut in in the molding process.