35 Quality Systems that grow customer trust We have built a robust Quality system across the value chain from drug development to drug delivery. The emphasis on product responsibility is reflected in continuous updates to our quality systems in accordance with the current regulatory requirements. Across Sai, a single quality system is followed, and it is designed to meet global quality standards (US/EU/Japan). Customer audit All our actions are shaped by an unwavering focus towards meeting and exceeding customer expectations regarding product and service quality. Key highlights of feedback received from various customers on quality performance based on their audits are: • Transparency and openness for discussion • Continual improvement of quality systems • Continually benchmarking our digitalization far above the industry • Robust implementation of GMP Pro system with a thorough integration of quality, material, production & engineering systems • Best documentation practices This provides an overview of the customer audits conducted throughout the reporting year Unit-II: 12 (No critical observations) Unit-III: 04 (No critical observations) Unit-IV: 21 (No critical observations) Digitalization We are transforming the way we collect, analyse, and interpret data by way of digitalization. This we believe will boost operational excellence, bring value to our customers and ultimately help in accelerating the pace of drug discovery. These are our major digitalization initiatives that have contributed to increased efficiency, innovation and transparency in our quality management systems. Quality control systems, document management systems, engineering systems, audit management systems at our research and manufacturing facilities were digitized during the reporting period. Automating these operations and reducing manual intervention has not only improved operational efficiency, but also reduced errors, improved data integrity, and strengthened compliance. GMP Pro, Laboratory Information Management System (LIMS), Automated Measuring Systems (AMS) , Learning Measuring Systems LMS, Electronic Lab Notebook (ELN), GOVAL digital validation lifecycle management systemPro, Laboratory Information GoVal GoVal is a Validation Lifecycle Management System (VLMS) that has been implemented for paperless validation and to fulfil regulatory compliance. These are its key features: • Retrospective validation and periodic review of GxP computerized systems • Standardized templates for document generation with customizable sections • Defined workflows for document approval and E-signatures applied for all the deliverables • System level & functional level risk assessment as per ICHQ9 • Paperless execution for IQ, OQ, PQ • Automated report generation for IQ, OQ, PQ, summary report and system release BIOVIA ELN was rolled-out for the MedChem and Biology teams across India and Boston. It replaced the paper-based notebooks and Sai ELN. Initially, a select set of projects and users were onboarded and gradually it was extended to the rest of the Discovery segment on a staggered basis. The BIOVIA ELN offered a seamless platform across Discovery and CMC segments. Benefits of the application: • Stronger IP protection • Seamless collaboration across all global sites • Lower compliance risk • Lower cycle time • Better productivity • Lower cost BIOVIA Electronic Lab Notebook application
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