Strengthening Quality Culture and Deviation Management with Digital Tools in Pharma
At CMC China 2025, Ivan Zhang, Consultant at Rephine China, delivered an insightful presentation on deviation management and quality culture — highlighting how digital tools can enable continuous improvement across the pharmaceutical sector.
This event was the perfect platform to showcase how Rephine combines global GxP expertise with local regulatory knowledge, supporting companies at every stage of their QA journey.
Deviation Management Presentation at CMC China
Ivan Zhang at CMC China
Ivan Zhang presenting
CMC China
Delivering Impactful presentation
CMC China 2025 – A Localised Yet Impactful Event
While smaller than global exhibitions like CPHI, CMC China offers a targeted, high-value environment. The audience includes senior decision-makers, Quality Heads, and QA professionals, with training sessions led by ex-regulators and industry experts from bodies such as NMPA and the Chinese Pharmacopoeia Committee.
Key takeaways about the event:
- Local focus, global relevance – Ideal for SMEs seeking growth opportunities.
- Direct engagement – Decision-makers with clear business objectives.
- Quality-driven – Sessions dedicated to compliance, registration, and regulatory change updates.
Quality Culture – Moving from Reactive to Proactive
Ivan opened his session by quoting FDA training principles:
A strong quality culture identifies and solves problems proactively and systematically.
He introduced the four maturity levels of quality culture:
- Reactive – Problems only addressed in crisis situations.
- Patchwork fixes – Willingness to change, but lacking systemic improvements.
- Proactive – Issues surfaced early and acted upon.
- Preventive – Continuous improvement embedded into daily practice.
Leadership commitment, investment in quality, and embedding quality in business decisions were identified as critical success factors.
Deviation Management – Overcoming Common Pain Points
Ivan addressed the real-world challenges of deviation management in pharma, from initial detection to final reporting:
Fear of reporting deviations due to KPI impact or management blame.
Overly complex processes and heavy paperwork.
Inaccurate, incomplete, or inconsistent documentation.
Lack of collaboration between QA and operational teams.
Insufficient root cause analysis and data integrity issues.
Solution: Clear responsibilities, structured investigation processes, and adoption of deviation management digital tools to simplify and standardise reporting.
Continuous Improvement Through Digitalisation
Ivan demonstrated how digital systems can revolutionise deviation management in pharma:
- Easy capture of all issues, big or small.
- Integrated analytics for identifying patterns and root causes.
- AI capabilities to highlight risks and predict future issues.
- Regular data reviews to ensure continuous improvement is part of management reviews and CAPA programmes.
Deploying simple, accessible digital tools isn’t just about efficiency — it’s about embedding a culture of continuous, preventive improvement
Why Rephine? Global Expertise, Local Insight
Rephine supports pharmaceutical companies worldwide with GMP consultancy, GxP readiness, and digitalisation strategies. Our experts combine international compliance knowledge with in-depth local understanding, enabling clients to strengthen quality culture, streamline deviation management, and adopt the right digital solutions for lasting impact.
📌 Wherever you are on your QA journey, we’ve got you covered.
👉 Learn more about our GMP Consultancy and Quality Culture Services
