Regulatory complexities in health-tech & life sciences demand precision, agility and unwavering compliance. Fragmented processes, evolving global standards and manual operations create barriers to innovation and speed-to-market. HARMAN intelligent-QARA (i-QARA) simplifies regulatory adherence with AI-led, next-gen solutions that automate compliance achieving process, enhance data integrity and accelerate approvals.
From AI-powered regulatory advisory and Computer System Validation (CSV) to Digi-QMS and post-market surveillance automation, HARMAN i-QARA ensures continual compliance across the product lifecycle. Advanced capabilities like Gen-AI powered content authoring, dossier management, transform regulatory documentation approach, while risk mitigation tools proactively address compliance gaps.
With HARMAN i-QARA, health-tech & life sciences organizations can reduce regulatory burdens and streamline workflows, ensuring safety, quality, performance, efficiency & efficacy alongside access to the global market.
