By: IPP Bureau
Last updated : June 22, 2026 4:57 pm
CDMO strengthens global quality framework through digital transformation, AI-enabled investigations, workforce development and continuous audit readiness
Piramal Pharma Solutions (PPS), a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd., has announced that it successfully completed more than 200 customer audits and received over 70 approvals from regulatory agencies across its global network during the past fiscal year.
The achievement reflects the company’s long-term quality strategy and ongoing commitment to scientific excellence, compliance, and continuous improvement.
According to the company, its quality framework is built on a combination of robust governance, quality-focused culture, workforce development, process harmonization, and digital transformation initiatives.
PPS has implemented a comprehensive quality governance framework supported by predictive quality tools that assess site readiness and compliance health. The company also utilizes tailored quality systems designed to improve efficiency, reduce the cost of poor quality, and proactively address evolving regulatory expectations.
A cornerstone of this strategy is the company's REsolute to SOLVE Deviations (RESOLVE) program, which promotes right-first-time execution across manufacturing operations and Quality Control (QC) laboratories.
The initiative is aimed at minimizing errors, improving process reliability, and ensuring timely preparedness for regulatory inspections and customer audits. Key elements of the program include concurrent batch record reviews, site-wide quality ownership, enhanced shopfloor quality oversight, and strengthened operational vigilance.
To further strengthen quality capabilities, PPS has introduced specialized training programs focused on audit readiness, regulatory engagement, and decision-making, enabling teams across the organization to maintain high standards of compliance and operational excellence.
Digitalization continues to play a central role in enhancing quality processes across the PPS network. Through its eLab platform, the company has digitized QC laboratory operations and automated testing workflows, helping improve efficiency, reduce errors, and enhance turnaround times. The exForms platform digitizes GxP documentation, supporting ALCOA compliance while improving document accessibility, accelerating approvals, and reinforcing continuous audit readiness.
In addition, PPS has adopted iAssist, a validated human-in-the-loop AI-enabled tool designed to improve the speed and consistency of quality investigations. The platform supports structured investigation processes, enhances output quality, and reduces manual effort for quality teams.
Rashida Najmi, Chief Quality Officer, Piramal Pharma Solutions, said, “At Piramal Pharma Solutions, quality is integral to everything we do. Our focus is on building quality into everyday operations so that audit readiness is sustained, not episodic. That discipline helps us deliver the consistency and reliability our customers expect.”