Recurring deviations—especially those involving the same or similar issues—are often red flags for regulatory inspectors. In many cases, significant inspection deficiencies related to inadequate corrective actions could have been prevented if the organisation had recognised the patterns earlier and taken proactive steps.
The challenge lies in the structure of many Quality Management Systems (QMS). Often, these systems are not designed to enable meaningful data integration or cross-referencing across processes, departments, or timelines. As a result, valuable information is stored in silos, making it difficult for anyone to "join the dots" and identify underlying systemic issues.
This lack of visibility can delay root cause analysis, compromise the effectiveness of CAPAs, and ultimately lead to repeat findings—something regulators view as a serious lapse in control.
In this webinar, SeerPharma Director Andrew Giles will share his insights and observations on the challenges posed by disconnected Quality Management Systems. Drawing from years of experience across regulatory inspections and client engagements, Andrew will highlight common pitfalls and missed opportunities that often result from fragmented data and siloed processes within quality frameworks.
Fortunately, there are practical strategies to overcome this. Modernising your QMS to support better data connectivity, improving cross-functional communication, and implementing tools for trending and analytics can significantly enhance your organisation’s ability to detect patterns, respond effectively, and stay ahead of compliance risks.
Investing in these improvements not only reduces the risk of regulatory deficiencies but also builds a culture of continuous improvement and operational resilience.
Following Andrew’s presentation, SeerPharma Director - Rohan Bhatia will present practical strategies for how digitisation can address these gaps. He will explore how modern digital tools from MasterControl can enhance data integration, enable real-time visibility, and support proactive decision-making—ultimately helping organisations ‘connect the dots’ within their Quality Systems and strengthen compliance readiness.
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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.
