Life Sciences Start-Ups: What You Need to Know About Phase Appropriate Quality Requirements

By Lisa Helmonds, Vice President of Quality and Operations, MWA Consulting, Inc., and Paul Andrea, Independent Consultant, MWA Consulting, Inc. (a subsidiary of Mastercontrol)

Implementing a robust digital quality management system (QMS) at the early phase of product development will help you comply with the ever-changing and more stringent regulations throughout the product life cycle. A well-designed digital QMS ensures high quality products are manufactured, challenges are managed appropriately, and all personnel are properly educated and trained to perform their functional tasks as appropriate. Remember you use this data to make critical decisions on whether to move forward with your programs, so the data must be compliant and demonstrate data integrity when submitted to any regulatory agency.

Given the appropriate design and level of complexity based on your company’s structure, a digital QMS system could be your most efficient and compliant solution to get your product to approval and improve the lives of your patients.

In this article we will discuss implementation of a phase-appropriate QMS and the importance of starting early in the product development life cycle, the disadvantages of using a manual paper-based QMS in the early phases and advantages to your company by using a digital QMS.