Alok Mehrotra, Chief Quality Officer, Syngene International presented a session on ‘Audit-proof pharma: Creating a culture of compliance’ on creating a culture of compliance that goes beyond simply meeting regulatory requirements. He began by emphasising that compliance is the true foundation of patient safety, product quality, and trust. With regulators worldwide raising expectations and audits becoming more rigorous, organisations cannot afford to treat compliance as a checkbox exercise. Instead, it must be seen as a strategic differentiator that ensures efficiency, market continuity and long-term competitiveness.
He underscored that compliance is not just the responsibility of quality assurance teams or senior management. It has to be embedded across the organisation, with every employee taking ownership of doing things right the first time. This cultural mindset helps companies remain resilient not only during regulatory audits but also in times of external disruptions such as supply chain crises or product recalls.
He introduced a three-pillar framework that integrates self-inspections, corporate audits, and Gemba walks. Mehrotra described self-inspections as powerful tools when conducted objectively, documented thoroughly, and followed by corrective actions that lead to real improvements. Corporate audits, on the other hand, bring independence and alignment with best practices. Gemba walks were presented as a key practice to bridge management and operations, allowing leaders to observe processes first-hand and promote a culture of accountability.
By weaving these three practices into an integrated system, companies can embed audit readiness into daily operations rather than scrambling to prepare only when an inspection is due. The result is a resilient quality ecosystem where transparency, proactive problem-solving, and continuous improvement are the norm. The speaker also pointed out that such an approach reduces stress on teams, builds regulator confidence, and safeguards reputations in a highly competitive market.
In conclusion, the session underscored that audit-proofing is not about eliminating audits, but about creating organisations that are always ready for them.