Pharmacovigilance, CSA/CSV Automation, and Labeling Innovation
Tech Mahindra has constructed a broad presence throughout the life sciences worth chain, from scientific and regulatory companies via manufacturing and put up‑market operations. Its emphasis on AI, automation, and knowledge‑pushed frameworks to enhance pace, high quality, and regulatory management, whereas supporting the operational wants of pharmaceutical and medical machine organizations, has led to its recognition in three key areas of the 2025 Pharmaceutical Expertise Excellence Awards: Security, Analysis and Improvement, and Innovation.
Tech Mahindra received the Security award within the Pharmacovigilance class for its shift from largely guide case processing to a extra built-in, AI‑enabled mannequin that strengthens compliance and threat monitoring. The corporate received the Analysis and Improvement award within the CSA/CSV Automation class for its pc software program assurance (CSA) and pc system validation (CSV) automation method, which makes use of AI‑pushed workflows to streamline validation whereas sustaining GxP and regulatory expectations. It obtained the Innovation award within the Labeling Automation class for its position in advancing labeling automation, connecting regulatory change administration with art work processes to cut back guide effort and enhance management over labeling updates.
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AI‑enabled pharmacovigilance to assist proactive drug and machine security
In pharmacovigilance (PV), Tech Mahindra strikes past a slender give attention to case processing by positioning security as a steady, knowledge‑pushed operate. Drawing on its expertise in triaging and processing antagonistic occasion instances for world purchasers, the corporate has assembled a framework that mixes 24/7 antagonistic occasion consumption, AI‑enabled analytics, and multi‑channel knowledge assortment right into a extra built-in PV atmosphere.
The answer suite covers the total PV lifecycle, together with antagonistic occasion assortment and comply with‑up, case entry and processing, medical coding, report writing, monitoring, and knowledge evaluation. It incorporates instruments for sign detection, social media sentiment and security evaluation, literature search and extraction, and actual‑world proof era. A dashboard layer gives security and regulatory intelligence, enabling aggregation and visualization of affected person security knowledge in ways in which assist regulatory and inside determination‑making necessities.
A key differentiator within the medical machine area is using automated IMDRF coding. Tech Mahindra’s AI, ML, and LLM‑primarily based functionality is described as the primary of its form for automated IMDRF coding and knowledge categorization throughout the seven annexes, with reported accuracy of round 95% in predicting related codes. This targets a step that’s usually guide and error‑inclined, with the intention of constructing machine security operations extra constant and fewer depending on repetitive human enter.
The corporate additionally applies automation to biomedical literature screening, which is a important enter for particular person case security reviews, mixture reporting, and sign detection. Its AI/ML mannequin for automated literature search and classification is reported to attain 97% accuracy and roughly 70% value financial savings in contrast with in‑home processing. This enables literature assessment actions to be dealt with at scale whereas sustaining a excessive classification commonplace.
Operational metrics from Tech Mahindra’s PV companies underpin the emphasis on each compliance and effectivity. Pharmacovigilance companies and dwell case processing for therapeutics and medical units are related to greater than sevenfold value financial savings, turnaround time compliance above 99%, and roughly 80% enchancment in turnaround time versus baseline. High quality compliance is reported at greater than 99%. Throughout greater than 350,000 processed instances, the corporate cites 100% TAT compliance and constant high quality scores exceeding 99.5% inside a six‑sigma optimized, multi‑channel atmosphere. In affected person assist program contexts, antagonistic occasion and critical antagonistic occasion reporting via CRM instruments is delivered with zero deviation from agreed key efficiency indicators (KPIs) and repair degree agreements (SLAs), supported by multilingual capabilities.
Importantly, pharmacovigilance is just not handled as an remoted operate. Tech Mahindra’s life sciences choices span protocol improvement, scientific knowledge administration, medical assessment, regulatory filings, medical and regulatory affairs, labeling, manufacturing, high quality, provide chain administration, and advertising and marketing assist. This broader footprint allows security knowledge and insights to be utilized throughout the continuum, from scientific improvement to put up‑market surveillance and labeling.
Agentic AI‑Pushed CSA/CSV automation for contemporary GxP validation
In R&D and GxP IT operations, Tech Mahindra focuses on the trade’s shift from conventional, documentation‑heavy CSV towards pc software program assurance. Its supplies underline that legacy CSV strategies will be inflexible and useful resource‑intensive, significantly for dynamic, cloud‑primarily based infrastructures and sophisticated methods comparable to MES, LIMS, ERP, and SCADA. The corporate frames CSA as a chance to rebalance validation efforts towards important pondering, threat‑primarily based testing, and automation, in keeping with evolving regulatory expectations.
The proposed method makes use of an “agentic AI” ecosystem to automate and streamline CSV/CSA processes. As an alternative of guide creation of core validation documentation and specs, Tech Mahindra defines a set of position‑primarily based AI brokers with specific objectives and contextual reminiscence. These embody brokers for validation venture administration, infrastructure specification, QA operations, threat administration, compliance validation, and exception dealing with. The brokers work from inputs comparable to enterprise requirement paperwork, blueprints, and venture metadata to generate core CSV paperwork, threat assessments, consumer necessities, useful necessities, and take a look at plans, whereas sustaining traceability and audit trails.
An vital focus is infrastructure validation as a vertical slice, with the intent to subsequently prolong the mannequin to functions. A six‑week proof of idea demonstrates how infrastructure technical specs, which beforehand required weeks or months of cross‑useful work amongst cloud, safety, and compliance SMEs, will be automated. The AI brokers translate enterprise inputs into detailed infrastructure specs that align with finest practices and regulatory expectations (together with AWS Effectively‑Architected rules, GxP controls, HIPAA, and ISO 27001). The PoC outcomes point out as much as 80% accuracy in AI‑generated infrastructure specs, as much as 70% discount in turnaround time for infrastructure specification creation, and as much as 100% compliance with safety insurance policies and regulatory requirements within the examined situations.
This automation helps a shift from a mannequin the place most validation effort is absorbed by documentation to at least one the place extra effort will be directed to threat‑primarily based testing and evaluation. The answer is designed to make sure that features important to product high quality and affected person security obtain targeted validation consideration, whereas low‑threat areas are dealt with extra effectively. Options comparable to lifecycle flexibility, steady validation assist, change management integration, and audit‑prepared doc repositories are positioned to enhance responsiveness to inspections and modifications with out reintroducing extreme guide work.
Tech Mahindra cites trade forecasts that time to a rising world CSV market, in addition to reviews that firms adopting CSA rules obtain 20–40% financial savings in validation efforts in contrast with conventional CSV, largely by concentrating on excessive‑threat features and leveraging automation. Tech Mahindra’s agent‑primarily based framework is introduced as a strategy to translate these rules right into a sensible, repeatable validation course of that may begin with infrastructure and scale to functions throughout the GxP system lifecycle.
Finish‑to‑finish labeling automation for regulatory change and art work administration
Tech Mahindra highlights labeling change administration as an space the place guide processes and low automation create operational and compliance threat. As life sciences firms handle extra merchandise and face rising volumes of native regulatory change requests, the necessity to hold labels and art work synchronized with permitted product info (PI) turns into extra complicated. Tech Mahindra’s work with the GLAMS Influence Evaluation resolution targets these challenges by automating key steps from regulatory change set off to art work execution.
The present state in lots of organizations depends on guide, spreadsheet‑primarily based art work affect evaluation, free‑kind updates to supply paperwork, and guide initiation of workflows in Art work Administration Methods (AMS). GLAMS Influence Evaluation addresses this by offering a single view of regulatory and art work information and related metadata, integrating with present Regulatory Data Administration (RIM) and AMS platforms. It makes use of superior algorithms and pure language processing to establish and extract modifications from drug product labeling paperwork. Tracked modifications in core, regional, or native product info are mechanically detected, and the system highlights “what’s modified” for evaluation. This reduces the effort and time historically required to find and interpret affected content material.
As soon as modifications are recognized, the answer helps detailed affect evaluation throughout art work parts comparable to textual content, format, and visuals. It paperwork potential impacts and downstream system implications, serving to groups perceive the total scope of required updates. GLAMS Influence Evaluation then automates the implementation part. Accepted modifications from Microsoft Phrase PI paperwork are repurposed and utilized as mark‑ups to associated art work PDF information, successfully creating an art work transient. The system then auto‑initiates mock‑up and manufacturing workflows throughout the AMS, with corresponding notifications and metadata dealing with. This shifts the method from guide file uploads and knowledge entry to a structured, automated chain ranging from the regulatory change set off.
The reported advantages of this method are important. GLAMS Influence Evaluation is related to as much as tenfold quicker supply from PI change affect identification to art work transient creation, roughly 50% effectivity achieve over present regulatory art work change planning actions, and as much as 20% discount in manufacturing prices. These good points are linked to fewer errors, decreased rework cycles, and improved “proper‑first‑time” creation of labels and promotional supplies. Sooner execution of labeling modifications additionally helps decreased time to marketplace for up to date product info, which is vital for affected person security and regulatory compliance.
From a governance perspective, the answer consists of regulatory content material model monitoring, knowledge lineage for content material and metadata, and detailed audit data. It helps batch and multi‑stage assessments, enabling a single supply of change to be assessed in opposition to a number of artworks and up to date in response to inside skilled assessment or well being authority suggestions. This contributes to raised visibility of consumer selections, change implications, and workflow progress, which is vital for inspection readiness and responses to labeling‑associated questions from well being authorities.
GLAMS Influence Evaluation is designed to be extensible past present processes. By integrating with metadata and content material in regulatory Phrase paperwork and art work property, the answer will be reused and prolonged to assist initiatives comparable to digital Product Data (ePI) and broader art work automation. Inside Tech Mahindra’s broader life sciences capabilities, this labeling automation work kinds half of a bigger effort to attach regulatory, security, and manufacturing operations via digital workflows.
“This award for innovation stands as a testomony to the numerous worth our domain-focused know-how brings to the Life Sciences sector. We’re proud to empower drug security groups, scientific leaders, and medical affairs specialists by simplifying complicated processes and accelerating important decision-making. Our differentiated art work, packaging, and labeling resolution continues to tell apart itself as an trade transformer. This accolade underscores our deep dedication to advancing the trade via cutting-edge know-how and, most significantly, enhancing affected person outcomes.”
Ravinder Singh, International Vertical Head – Healthcare and Life Sciences (HLS)
Firm Profile
Tech Mahindra (NSE: TECHM) gives know-how consulting and digital options to world enterprises throughout industries, enabling transformative scale at unparalleled pace. With 152,000+ professionals throughout 90+ nations serving to 1100+ purchasers, Tech Mahindra gives a full spectrum of companies together with consulting, info know-how, enterprise functions, enterprise course of companies, engineering companies, community companies, buyer expertise & design, Al & analytics, and cloud & infrastructure companies. It’s the first Indian firm on this planet to have been awarded the Sustainable Markets Initiative’s Terra Carta Seal, which acknowledges world firms which can be actively main the cost to create a local weather and nature-positive future. Tech Mahindra is a part of the Mahindra Group, based in 1945, one of many largest and most admired multinational federation of firms. For extra info on how TechM can accomplice with you to satisfy your Scale at Pace™ imperatives, please go to https://www.techmahindra.com/.
Yogi Pendli
Advertising Group Supervisor
Tech Mahindra Restricted
Hyperlinks
Web site: https://www.techmahindra.com/
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