Catégorie : Services

Cost of Quality & Management

Our approach provides tools to determine the extent to which resources are used for activities that prevent poor quality, that appraise the quality of products and services, and that result from internal and external failures.

Cost of Quality is much more complex than considering scraps and workforces costs. Indeed, limiting the Cost of Quality to these two cost drivers minimizes by far not only the financial spends, but also the opportunities for improvement. Pharmaceutical Companies should invest on Right First Time Quality (Quality by Design), beyond fixing issues and addressing compliance gaps. A more efficient way to look at spends for Quality should consider the cost of Compliance, the cost of Continuous Improvement, and the Cost of Poor Quality. D2C will support you to implement such an approach and install a new mindset.

QMS Implementation

Should you be in Pharmaceutical development of delivering commercial products, D2C Life Science supports you for implementing the right size QMS, Compliant, Effective, and Scalable. We also offer Dashboards and KPIs solutions to drive your performance based on Data.

D2C Life Science will support you for the implementation or the upgrade of your Quality Management System. Documentation is key in our business, but it’s not only about documentation. Indeed, we consider the real needs from a company perspective, we help in elaborating the right size QMS structure, should it be ISO or GMP based. In addition, D2C Life Science connects the QMS architecture with the necessary digital tools, and adequate KPIs to ensure the best governance of your Quality System. With this approach, we build for you a pro-active QMS applicable to internal and external Quality.

Quality Assurance 4.0

The Digital transformation is not optional in the industry, and particularly in the Pharmaceutical Industry where everything goes faster and Data Management is the new challenge.

At D2C Life Science, we connect the dots and everything we do is closely related to Digitalization. Data Driven Compliance includes the proper utilization of Data in the decision making process, but also leads to a more proactive Quality Management. With the QA 4.0 Concept, we aim to leverage digital capabilities to increase awareness, implement intelligent solutions for managing Quality, and ensuring a consistent and sustainable process over time. Integrating all these aspects in a consolidated roadmap provides the necessary visibility and contributes to elaborate a strong Digital Strategy.

Quality Risk Management

Beyond the mandatory compliance to Standards regarding Quality Risk Management, the concept is key for achieving great results and making the right decisions. A Quality Risk Management process should provide a clear visibility on risks, priorities and also identify “blind spots."

Our QRM approach is based on a proprietary tool developed by D2C Life Science, able to calculate a risk rating using clear definitions, for a pre-defined list of risks. The calculation leads to discriminant results and therefore enables priority settings. Our tool is customizable and provides a holistic view of all risks within a site or across the entire organization, dynamic in a sense that external factors, when evolving, will affect the risk scores and provide awareness on an emerging risk. The customer experience of such an approach is that everyone involved in the exercise learns a lot on their own processes. Combined to the Cost of Quality Concept proposed by D2C Life Science, our concept becomes a powerful process for resources allocation and Quality Organization Effectiveness.

CMO Oversight

From a contract giver and also from a CMO perspective, strong processes must be in place and more important, the relationship between customers and suppliers must be based on clear rules, with a continuous and open communication channel. That’s the purpose of our model.

CMO Oversight is key for contract givers, and as for other activities we offer, our concept is based on Data. The CMO network is evaluated thanks to a proprietary tool, including an assessment for both Business and Quality/Compliance aspects, completed by a deeper analysis of the CMO Quality performance when necessary. A visual representation of risks, performance, and areas of concerns contributes to a better management and ensures the necessary oversight for an effective CMO management.

Quality Excellence

Our interaction with customers goes beyond QMS optimization and fixing issues. Indeed, when involved in a remediation project, or for an Inspection readiness program, D2C Life Science targets pragmatic and actionable solutions. Quality Excellence is our target, which means effective compliance, in a sustainable way, and Data driven.

Issues must be fixed, and while fixing issues, we must consider what failed in the current process leading to the Issue. The process is re-designed accordingly in a permanent way, and we include the necessary tools and governance models to properly execute the re-designed process. Finally, in order to ensure sustainability in performance, D2C Life Science proposes and implements the KPIs and Dashboards that will provide the Organization the ability to drive Quality in a compliant and effective manner. That’s Quality Excellence.