Data Integrity failures remain one of the most common reasons for regulatory action in the pharmaceutical industry and continue to be among the most frequently cited findings in inspections globally. Notably, approximately 60% of these failures could be avoided with the implementation of robust data governance frameworks.
As part of our consulting engagements, SeerPharma is frequently engaged by clients to review and assess their approach to managing Data Integrity. To gain insights into some of our key observations, we invite you to read our article: Data Integrity - Intentional, Unintentional and Potential
In other cases, clients engage us to digitise their Quality Management System (QMS) workflows—helping to address data silos and strengthen oversight of operational activities. Through our partnership with market-leading software platform MasterControl, we support clients in implementing a mature and integrated electronic QMS (eQMS) that enhances visibility and control over critical data processes.
In response to industry demand, SeerPharma Senior Consultant Abraham John and Business Development Manager Anil Pendurthi will host a joint webinar on Wednesday the 16th of July. The session will focus on strengthening Data Integrity through embedded governance and feature a demonstration of key MasterControl functionalities that address common Data Integrity challenges.
This webinar will explore how organisations can shift from reactive compliance to proactive, risk-based practices.
Key topics to be covered include:
- The evolution of Data Integrity expectations—from paper-based systems to digital platforms
- The critical role of ALCOA+ principles in ensuring compliant and trustworthy records
- The influence of organisational culture in supporting (or undermining) data governance
- Regulatory trends and expectations from the FDA, MHRA, EMA, and PIC/S authorities
- Practical steps toward implementing a risk-based data governance framework
- Techniques for mapping data risks (High, Medium, Low) and applying proportionate controls
Abraham will provide practical guidance on how organisations can:
- Determine appropriate frequency and scope for audit trail reviews
- Differentiate between batch/data audit trails and system audit trails
- Define clear, SOP-aligned roles and responsibilities for Data Integrity oversight
Anil will provide attendees a brief (10min) overview of how MasterControl helps our clients address DI challenges such as:
- Audit Logs and trails of documentation
- User access control
- How different versions of the same document can be saved in the system without getting deleted
- How a controlled copy can be generated with an expiry time set at the time of generation
Watch this free webinar to explore best practices in Data Integrity and governance.
This initiative reflects our ongoing mission to Advance Quality and GMP Best-Practices across the Asia-Pacific region for the pharmaceutical and medical device industries.
