Tech Mahindra has built a broad presence across the life sciences value chain, from clinical and regulatory services through manufacturing and post‑market operations. Its emphasis on AI, automation, and data‑driven frameworks to improve speed, quality, and regulatory control, while supporting the operational needs of pharmaceutical and medical device organizations, has led to its recognition in three key areas of the 2025 Pharmaceutical Technology Excellence Awards: Safety, Research and Development, and Innovation.
Tech Mahindra won the Safety award in the Pharmacovigilance category for its shift from largely manual case processing to a more integrated, AI‑enabled model that strengthens compliance and risk monitoring. The company won the Research and Development award in the CSA/CSV Automation category for its computer software assurance (CSA) and computer system validation (CSV) automation approach, which uses AI‑driven workflows to streamline validation while maintaining GxP and regulatory expectations. It received the Innovation award in the Labeling Automation category for its role in advancing labeling automation, connecting regulatory change management with artwork processes to reduce manual effort and improve control over labeling updates.
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AI‑enabled pharmacovigilance to support proactive drug and device safety
In pharmacovigilance (PV), Tech Mahindra moves beyond a narrow focus on case processing by positioning safety as a continuous, data‑driven function. Drawing on its experience in triaging and processing adverse event cases for global clients, the company has assembled a framework that combines 24/7 adverse event intake, AI‑enabled analytics, and multi‑channel data collection into a more integrated PV environment.
The solution suite covers the full PV lifecycle, including adverse event collection and follow‑up, case entry and processing, medical coding, report writing, monitoring, and data analysis. It incorporates tools for signal detection, social media sentiment and safety analysis, literature search and extraction, and real‑world evidence generation. A dashboard layer provides safety and regulatory intelligence, enabling aggregation and visualization of patient safety data in ways that support regulatory and internal decision‑making requirements.
A key differentiator in the medical device space is the use of automated IMDRF coding. Tech Mahindra’s AI, ML, and LLM‑based capability is described as the first of its kind for automated IMDRF coding and information categorization across the seven annexes, with reported accuracy of around 95% in predicting relevant codes. This targets a step that is typically manual and error‑prone, with the aim of making device safety operations more consistent and less dependent on repetitive human input.
The company also applies automation to biomedical literature screening, which is a critical input for individual case safety reports, aggregate reporting, and signal detection. Its AI/ML model for automated literature search and classification is reported to achieve 97% accuracy and approximately 70% cost savings compared with in‑house processing. This allows literature review activities to be handled at scale while maintaining a high classification standard.
Operational metrics from Tech Mahindra’s PV services underpin the emphasis on both compliance and efficiency. Pharmacovigilance services and live case processing for therapeutics and medical devices are associated with more than sevenfold cost savings, turnaround time compliance above 99%, and roughly 80% improvement in turnaround time versus baseline. Quality compliance is reported at more than 99%. Across more than 350,000 processed cases, the company cites 100% TAT compliance and consistent quality scores exceeding 99.5% within a six‑sigma optimized, multi‑channel environment. In patient support program contexts, adverse event and serious adverse event reporting through CRM tools is delivered with zero deviation from agreed key performance indicators (KPIs) and service level agreements (SLAs), supported by multilingual capabilities.
Importantly, pharmacovigilance is not treated as an isolated function. Tech Mahindra’s life sciences offerings span protocol development, clinical data management, medical review, regulatory filings, medical and regulatory affairs, labeling, manufacturing, quality, supply chain management, and marketing support. This broader footprint enables safety data and insights to be applied across the continuum, from clinical development to post‑market surveillance and labeling.
Agentic AI‑Driven CSA/CSV automation for modern GxP validation
In R&D and GxP IT operations, Tech Mahindra focuses on the industry’s shift from traditional, documentation‑heavy CSV toward computer software assurance. Its materials underline that legacy CSV methods can be rigid and resource‑intensive, particularly for dynamic, cloud‑based infrastructures and complex systems such as MES, LIMS, ERP, and SCADA. The company frames CSA as an opportunity to rebalance validation efforts toward critical thinking, risk‑based testing, and automation, in line with evolving regulatory expectations.
The proposed approach uses an “agentic AI” ecosystem to automate and streamline CSV/CSA processes. Instead of manual creation of core validation documentation and specifications, Tech Mahindra defines a set of role‑based AI agents with explicit goals and contextual memory. These include agents for validation project management, infrastructure specification, QA operations, risk management, compliance validation, and exception handling. The agents work from inputs such as business requirement documents, blueprints, and project metadata to generate core CSV documents, risk assessments, user requirements, functional requirements, and test plans, while maintaining traceability and audit trails.
An important focus is infrastructure validation as a vertical slice, with the intent to subsequently extend the model to applications. A six‑week proof of concept demonstrates how infrastructure technical specifications, which previously required weeks or months of cross‑functional work among cloud, security, and compliance SMEs, can be automated. The AI agents translate business inputs into detailed infrastructure specifications that align with best practices and regulatory expectations (including AWS Well‑Architected principles, GxP controls, HIPAA, and ISO 27001). The PoC results indicate up to 80% accuracy in AI‑generated infrastructure specifications, up to 70% reduction in turnaround time for infrastructure specification creation, and up to 100% compliance with security policies and regulatory standards in the tested scenarios.
This automation supports a shift from a model where most validation effort is absorbed by documentation to one where more effort can be directed to risk‑based testing and analysis. The solution is designed to ensure that functions critical to product quality and patient safety receive focused validation attention, while low‑risk areas are handled more efficiently. Features such as lifecycle flexibility, continuous validation support, change control integration, and audit‑ready document repositories are positioned to improve responsiveness to inspections and changes without reintroducing excessive manual work.
Tech Mahindra cites industry forecasts that point to a growing global CSV market, as well as reports that companies adopting CSA principles achieve 20–40% savings in validation efforts compared with traditional CSV, largely by concentrating on high‑risk functions and leveraging automation. Tech Mahindra’s agent‑based framework is presented as a way to translate these principles into a practical, repeatable validation process that can start with infrastructure and scale to applications across the GxP system lifecycle.
End‑to‑end labeling automation for regulatory change and artwork management
Tech Mahindra highlights labeling change management as an area where manual processes and low automation create operational and compliance risk. As life sciences companies manage more products and face rising volumes of local regulatory change requests, the need to keep labels and artwork synchronized with approved product information (PI) becomes more complex. Tech Mahindra’s work with the GLAMS Impact Analysis solution targets these challenges by automating key steps from regulatory change trigger to artwork execution.
The current state in many organizations relies on manual, spreadsheet‑based artwork impact assessment, free‑form updates to source documents, and manual initiation of workflows in Artwork Management Systems (AMS). GLAMS Impact Analysis addresses this by providing a single view of regulatory and artwork files and associated metadata, integrating with existing Regulatory Information Management (RIM) and AMS platforms. It uses advanced algorithms and natural language processing to identify and extract changes from drug product labeling documents. Tracked changes in core, regional, or local product information are automatically detected, and the system highlights “what’s changed” for assessment. This reduces the time and effort traditionally required to locate and interpret affected content.
Once changes are identified, the solution supports detailed impact assessment across artwork elements such as text, format, and visuals. It documents potential impacts and downstream system implications, helping teams understand the full scope of required updates. GLAMS Impact Analysis then automates the implementation phase. Approved changes from Microsoft Word PI documents are repurposed and applied as mark‑ups to related artwork PDF files, effectively creating an artwork brief. The system then auto‑initiates mock‑up and production workflows within the AMS, with corresponding notifications and metadata handling. This shifts the process from manual file uploads and data entry to a structured, automated chain starting from the regulatory change trigger.
The reported benefits of this approach are significant. GLAMS Impact Analysis is associated with up to tenfold faster delivery from PI change impact identification to artwork brief creation, approximately 50% efficiency gain over current regulatory artwork change planning activities, and up to 20% reduction in manufacturing costs. These gains are linked to fewer errors, reduced rework cycles, and improved “right‑first‑time” creation of labels and promotional materials. Faster execution of labeling changes also supports reduced time to market for updated product information, which is important for patient safety and regulatory compliance.
From a governance perspective, the solution includes regulatory content version tracking, data lineage for content and metadata, and detailed audit records. It supports batch and multi‑stage assessments, enabling a single source of change to be assessed against multiple artworks and updated in response to internal expert review or health authority feedback. This contributes to better visibility of user decisions, change implications, and workflow progress, which is important for inspection readiness and responses to labeling‑related questions from health authorities.
GLAMS Impact Analysis is designed to be extensible beyond current processes. By integrating with metadata and content in regulatory Word documents and artwork assets, the solution can be reused and extended to support initiatives such as electronic Product Information (ePI) and broader artwork automation. Within Tech Mahindra’s broader life sciences capabilities, this labeling automation work forms part of a larger effort to connect regulatory, safety, and manufacturing operations through digital workflows.
“This award for innovation stands as a testament to the significant value our domain-focused technology brings to the Life Sciences sector. We are proud to empower drug safety teams, clinical leaders, and medical affairs specialists by simplifying complex processes and accelerating critical decision-making. Our differentiated artwork, packaging, and labeling solution continues to distinguish itself as an industry transformer. This accolade underscores our deep commitment to advancing the industry through cutting-edge technology and, most importantly, enhancing patient outcomes.”
Ravinder Singh, Global Vertical Head – Healthcare and Life Sciences (HLS)
Company Profile
Tech Mahindra (NSE: TECHM) offers technology consulting and digital solutions to global enterprises across industries, enabling transformative scale at unparalleled speed. With 152,000+ professionals across 90+ countries helping 1100+ clients, Tech Mahindra provides a full spectrum of services including consulting, information technology, enterprise applications, business process services, engineering services, network services, customer experience & design, Al & analytics, and cloud & infrastructure services. It is the first Indian company in the world to have been awarded the Sustainable Markets Initiative’s Terra Carta Seal, which recognizes global companies that are actively leading the charge to create a climate and nature-positive future.
Tech Mahindra is part of the Mahindra Group, founded in 1945, one of the largest and most admired multinational federation of companies. For more information on how TechM can partner with you to meet your Scale at Speed™ imperatives, please visit https://www.techmahindra.com/.
Contact Details
Yogi Pendli
Marketing Group Manager
Tech Mahindra Limited
Links
Website: https://www.techmahindra.com/
