A Step-By-Step Approach To Implementing Quality Infrastructure

By Meghna Sengupta and Austin Potthoff, Project Farma

New drug approval doesn’t happen without quality data. When data is misplaced or inaccessible, it can delay or increase risks to the drug development process. However, many pharmaceutical and biotech companies continue to operate with data management infrastructures that aren’t designed for the current expectations of our industry or still use paper records to store vital information. Regulatory authorities no longer see paper-based systems as sufficient because electronic systems are more traceable, accurate, and reliable while providing a digital environment that increases the utilization, application, and power of the data generated during the drug development and manufacturing processes. Also, they don’t necessarily cost more since electronic Quality Management Systems’ startup expenses can be counterbalanced by reducing staff hours otherwise dedicated to creating handwritten records.

Investing in quality infrastructure helps ensure data integrity and regulatory compliance. But how can companies upgrade their systems without shutting down their studies? The solution is a phased approach that allows companies to gradually shift to a better, more efficient system without compromising study timelines.

Companies should evaluate their quality infrastructure at critical pressure points, including:

• Regulatory health authority requirements
• Product life cycle requirements (Preclinical, Phase I/II clinical, Phase III/Commercial)
• Organizational growth
• Product portfolio and product demand
• Internal and external audits