SPK & Associates LLC
State of Digital Quality Maturity in Pharma and Medtech
Pages
22
Time to read
34 mins
Publication
Language
English
Pages
22
Time to read
34 mins
Publication
Language
English
This research report investigates the current state of digital quality maturity within the pharmaceutical and medical technology sectors. It outlines the challenges faced by quality professionals and the impact of technology on their workflows. The report is based on insights gathered from 152 quality leaders across various life sciences companies, highlighting their approaches to quality management and digital transformation. A quality maturity model is introduced, categorizing organizations into four tiers: manual, digital, connected, and intelligent. Key findings reveal that while 85% of companies have a Quality Management System (QMS), many do not fully leverage its capabilities. The report details the correlation between company size and the prioritization of digital transformation initiatives, noting that larger companies are more likely to prioritize these efforts. Additionally, it discusses common pain points in quality management, such as manual processes and challenges in audits, emphasizing the need for a more integrated digital approach to enhance efficiency and compliance.