Accelerating Operational Readiness & Excellence PDF

ACCELERATING OPERATIONAL READINESS AND EXCELLENCE How Technology-Enabled Services Drive Innovation in Regulated Industries CAI is bringing cutting-edge technology, including AI, to life sciences and mission critical facilities to save time, improve performance, reduce mistakes and achieve complianc...

ACCELERATING OPERATIONAL READINESS AND EXCELLENCE How Technology-Enabled Services Drive Innovation in Regulated Industries CAI is bringing cutting-edge technology, including AI, to life sciences and mission critical facilities to save time, improve performance, reduce mistakes and achieve compliance. TABLE OF Overview 04 The Changing Landscape of Regulated Industries The Growing Role of Technology CONTENTS The Rise of Artificial Intelligence 10 Technology Solutions Technology in Operational Readiness Case Study: Pfizer Asset Management Using Reality Capture Technology in Operational Excellence Case Study: AutoLOTO Sets New Standard for Safety and Efficiency 17 Featured Technologies Digital Twin AutoLOTO Technical Summarization AI Application Knowledge Graphs/Unified Intelligence Electronic Validation Lifecycle Management System (eVLM) Implementation AI-Enabled eVLM Other Technologies Case Study: Achieving Faster Timelines and Cost Savings with Kneat 23 The Future is Now Staying at the Forefront of Innovation Why You Should Start Your Digital Journey Getting Started OVERVIEW 5 OV ERV I EW AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E THE CHANGING LANDSCAPE OF REGULATED INDUSTRIES In industries already known for high stakes and even Technology holds the key to overcoming many of these higher demands, the degree of difficulty seems to be challenges. However, even that brings its own set of increasing. Manufacturers in life sciences facilities like concerns. The U.S. Food and Drug Administration (FDA) pharmaceutical manufacturing plants and mission critical recently released draft guidance on the use of artificial facilities such as data centers face constant pressure to intelligence in pharmaceutical development. The guidance adapt in the face of significant and rapid change. provides a risk-based assessment framework that aims to build credibility and trust in the use of AI, ensure As these are highly regulated industries, compliance will transparency in modeling and methods and manage the always be a challenge. In today’s environment, there is accuracy and relevance of data. growing regulatory scrutiny and more complex compliance requirements. The use of AI and the FDA’s subsequent guidance are a microcosm of the changes regulated industries are facing Against this backdrop of expected perfection come and how they are addressing them. They also show that additional demands. The manufacturing process, for technology, when used properly, can lead to innovations example, is becoming increasingly complex, calling for that are both compliant and impactful. innovative solutions. The data that feeds much of the decision-making can become unwieldy or outdated, requiring stringent data quality and vigilant governance. On top of it all, to avoid costly delays, there is rising demand for faster time-to-market and operational efficiency. 6 OV ERV I EW AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E THE CASE FOR CHANGE Manufacturers and operators navigating this new world Manufacturers and operators must embrace technology are looking to technology to solve these core issues: to keep up with industry demands such as, Time Mistakes Compliance Capacity Agility Sustainability Time is money, and when project With increasing regulatory scrutiny, With tools to address everything With AI accelerating R&D The future of regulated industries AI and quantum computing are delays can cost millions of dollars, and deviations driving up costs, from documentation to data breakthroughs, the industry must isn’t just about scale—it’s about reshaping entire industries, but this becomes even more evident. outdated methods to prevent analysis, technology can provide expand the limits of manufacturing building a manufacturing and facility they come with enormous energy Leveraging technology can save time mistakes are no longer sufficient. more quality and consistency and infrastructure capacity to network that can adapt. AI-powered demands. The companies and on tasks, accelerate readiness and Tech-enabled solutions can minimize with regulatory adherence. avoid bottlenecks. Digital twins, knowledge management, predictive facilities that thrive will be those that speed up time-to-market. mistakes and deviations and allow Meanwhile, as the pace of AI-driven process optimization and analytics and digital twins enable adopt energy-efficient, technology- faster work with less error and waste. innovation accelerates, that modular, tech-enabled facilities faster facility start-ups, seamless enabled operational strategies from brings additional challenges. allow companies to scale production process changes and real-time the ground up. Smart automation, faster and bring therapies to market decision-making. In manufacturing, an AI-driven facility optimization and without delays. Similarly, the demand agile network of smart facilities can predictive energy management for high-performance computing flexibly adjust production volumes, will be essential to maintaining is skyrocketing, requiring more adapt to regulatory shifts and handle sustainable operations while mission critical facilities to support AI, complex, high-variability products like meeting the escalating demands quantum computing and other data- personalized medicine. For mission of next-generation computing and intensive technologies. Organizations critical facilities, agility means being manufacturing. that don’t invest in scalable, future- able to integrate new AI workloads, ready infrastructure will fall behind. optimize energy use and future-proof data center operations. Companies that aren’t adopting these technologies now risk getting left behind to play catch-up later. A partner like CAI, at the forefront of innovation, can future-proof your company’s operations. 7 OV ERV I EW AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E THE GROWING ROLE Technology is the great equalizer. When modern demands Digital tools are enabling innovation throughout require things to be done better, faster and cheaper, manufacturing environments. Artificial intelligence, tech-enabled solutions make it possible. A partner like machine learning and advanced analytics can dramatically OF TECHNOLOGY CAI brings deep industry expertise and top-tier talent reduce the time required for certain tasks, minimize along with technology-driven solutions that accelerate errors and maximize efficiency. In other words, emerging operational readiness and operational excellence while technologies must be a part of any facility’s operational ensuring quality. readiness or operational excellence plan. Successful organizations are using these tools to: Enhance the decision-making process Improve quality control and Accelerate product development Optimize resource allocation reduce deviations and time-to-market and scheduling Data-driven insights and AI-powered predictive analytics can accelerate problem-solving and lead to better Technology and intelligence can automate tasks, reduce The use of digital tools and AI will speed up the process of Making certain tasks more efficient allows for more business decisions. the potential for human error and identify systemic issues getting plants ready for operation. Automation can shorten focus on high-value activities and core execution. that could lead to ongoing deviations if not detected. the time required for everything from documentation and validation to data analysis and investigations. 8 OV ERV I EW AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E THE RISE OF ARTIFICIAL INTELLIGENCE Artificial intelligence (AI) has ushered in a new era of The most common use of spatial AI in operational operational readiness and operational excellence, readiness and operational excellence is digital twin with tools that improve the speed and/or quality of technology. A digital twin is a digital replica of a facility numerous processes. or object overlaid with real-time data that leverages AI for things like asset management, maintenance Two significant categories of AI in operational readiness or commissioning. and excellence are cognitive AI and spatial AI. Applications of cognitive AI in operational readiness Cognitive AI involves natural language processing (NLP) and excellence leverage LLMs and retrieval augmented and artificial intelligence techniques that enable systems generation (RAG), which pulls information from a specific to understand, summarize and generate human-like text. data set or documentation. Such uses include knowledge Large language models (LLMs), such as GPT-based AI, graphs, AI summarizations and AI-enabled electronic analyze vast amounts of structured and unstructured text validation lifecycle management systems (eVLM). to automate knowledge retrieval, report generation and (These technologies will be covered in more depth regulatory compliance. later in this eBook.) Spatial AI creates intelligent digital representations of Deviation analysis provides a good example of this in physical assets, systems and processes by integrating practice. Intelligence models can quickly analyze large real-time sensor data, computer vision and machine amounts of data and find patterns that humans might miss. learning. This technology enables advanced visualization, This helps identify systemic issues in deviations faster predictive analytics and process optimization, allowing than traditional methods, significantly reducing the time organizations to simulate, monitor and improve real-world and cost of processing deviations and investigations, operations in industries such as manufacturing, healthcare preventing future similar errors and improving overall and infrastructure. quality of compliance. 9 AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E Digital Twin for Reality and Process (RC + CV + SRA + KG) True-to-life facility representation with integrated product and process knowledge Synaptic Impact (KG + NLP + LLM + AR) AI-powered compliance/efficiency analysis with contextualized visualization for operational excellence AI’S DUAL APPROACH Commissioning and Qualification CoPilot (RC + SLAM + SR + KG + NLP) Automated C&Q workflows and facility audits for operational readiness Intelligent Batch Record Review (LLM + RAG + CV + KG) Digital assistant for batch record review and scans and highlights compliance risks Combining Cognitive AI cognitive and Spatial AI spatial AI to generate Large Language Model (LLM) Reality Capture (RC) powerful results Retrieval Augmented Generation (RAG) Simultaneous Location and Mapping (SLAM) Natural Language Processing (NLP) Computer Vision (CV) Knowledge Graphs (KG) Augmented Reality (AR) Name Entity Recognition (NER) Spatial Reasoning AI (SR) TECHNOLOGY SOLUTIONS 11 TEC HN OLOGY SOLUTION S AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E TECHNOLOGY IN OPERATIONAL READINESS Clients must ensure their facilities are fully compliant and Our technology strategy prioritizes optimizing engineers’ production-ready. Digital tools such as artificial intelligence, time for high-value activities. Rather than burdening digital twins, digital workflows and knowledge graphs are them with time-consuming administrative tasks, we use transforming how organizations accelerate operational automation and AI to streamline workflows, allowing readiness, improving efficiency and reducing risk. them to focus on rigorous testing and validation. With our planned technology investments, we aim to automate 40 Every day a project is delayed has significant percent of the commissioning, qualification and validation consequences—missed revenue, competitive (CQV) process, 70 percent of summary reports and 50 disadvantages and even delays in delivering life-saving percent of drawing verification. In addition, we will see therapies to patients. Our technology-driven approach up to an 80 percent reduction in document development ensures that even when unexpected challenges arise, time, a 90 percent acceleration in technical summarization we can still deliver on our operational readiness promise: and AI-driven inspection augmentation of facility on time, on budget and in full. By integrating AI and specifications—saving thousands of hours that would automation into core processes, we help clients regain lost otherwise be spent on manual verification. time, optimize resource utilization and maintain compliance with evolving regulatory requirements. Digital tools are not just an enhancement—they are a necessity for organizations striving to reduce time-to- market, ensure regulatory compliance and maintain a competitive edge. At CAI, we combine deep industry expertise with cutting-edge technology to drive real results in operational readiness, making the process faster, more thorough and more cost-effective for clients. 12 TEC HN OLOGY SOLUTION S AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E Tech-enabled solutions CAI uses for operational readiness address: Automation to speed up Comprehensive regulatory Better data for better Virtual facility modeling Accurate asset inventory manual processes compliance decision-making and testing and maintenance planning Using artificial intelligence to create Knowledge graphs connect and structure By using knowledge graphs to structure A digital twin allows for simulating changes Using high-resolution 3D scanning and and review protocols for installation and previously siloed data, breaking down barriers and link critical data sources into a unified or testing procedures before implementing AI-driven asset mapping, reality capture operational qualification (IOQ) testing can between disparate systems and transforming intelligence platform, we enhance decision- them in the real facility, potentially catching creates a comprehensive, real-time digital significantly cut down the labor-intensive compliance tracking into an intelligent, making, improving speed and access to vital issues early. inventory of a facility’s assets. This allows documentation process in CQV projects. easily accessible framework. By automating information for teams across the organization. teams to accurately visualize, track and data retrieval, improving traceability and optimize operations—enhancing maintenance accelerating audits, this technology ensures planning, reducing downtime and improving teams have the right information at the right lifecycle management. time to maintain compliance and streamline regulatory reporting. 13 TEC HN OLOGY SOLUTION S AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E C A S E S T U DY PFIZER ASSET MANAGEMENT USING REALITY CAPTURE CAI helped Pfizer (formerly Seagen) create a digital twin of eight buildings, totaling 750,000 square feet in Bothell, Washington, for a campus-wide asset induction project. CAI’s team developed comprehensive asset master data, maintenance and calibration plans and a new spare parts stocking strategy, resulting in a fully populated digital twin that Pfizer continues to use daily for facilities planning and management. The solution reduced Pfizer’s maintenance planning by 3,000 hours a year, saving the equivalent of 1.5 full-time employees. Industry standard for asset management projects of this scope is 4-6 months. CAI delivered the project in 2.5 months and 25 percent under budget. Read the full case study. 14 TEC HN OLOGY SOLUTION S AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E TECHNOLOGY IN OPERATIONAL EXCELLENCE Facilities in regulated industries must operate at the Additionally, reality capture and asset inventory from highest standard of excellence, requiring seamless operational readiness seamlessly integrate into digital collaboration between quality, operations and engineering workflows, enabling immersive, mobile-enabled teams. Too often, critical knowledge is locked in silos, Gemba Walk programs that enhance facility oversight. slowing down decision-making and increasing operational These tools provide an unprecedented level of real-time risks. At CAI, we leverage knowledge graphs, IIoT-driven visibility, accuracy and efficiency, driving true predictive maintenance and digital twin technologies to operational excellence. connect knowledge domains, enable smarter workflows and drive higher reliability. By integrating edge devices and IIoT sensors, we establish a real-time baseline of equipment performance during qualification—allowing organizations to leverage this data for predictive maintenance and eliminate redundant future qualification testing. Meanwhile, digital twin and reality capture technologies empower engineers to test and optimize process changes virtually, ensuring success before execution in manufacturing and avoiding costly unintended consequences. 15 TEC HN OLOGY SOLUTION S AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E Tech-enabled solutions CAI uses for operational excellence address: Connected intelligence for better Predictive maintenance and reliability Virtual testing and simulation Immersive and mobile Gemba Walks Safe and efficient lockout/ insights and decision-making tagout procedures By integrating IIoT sensor data captured Digital twin technology enables engineers to Reality capture integrates with workflow Knowledge graphs break down information during qualification, we establish a simulate and test process changes in a virtual automation to transform Gemba Walk AutoLOTO combines digital twin technology silos, connecting quality, operations and performance baseline for equipment health. environment before implementing them programs into a seamless, immersive with digital workflow automation, ensuring engineering data into a unified intelligence This baseline is leveraged for ongoing in manufacturing. This reduces the risk of experience. By leveraging high-resolution 3D that lockout/tagout procedures are executed platform. This enables faster decision-making, predictive maintenance, reducing unexpected failure, prevents unintended consequences scanning and real-time facility data, teams can safely, efficiently and in compliance with improved compliance tracking and cross- failures while eliminating unnecessary and ensures modifications are optimized conduct remote and mobile Gemba Walks, regulations—minimizing downtime while functional insights that eliminate inefficiencies requalification testing in the future. before execution. improving oversight, issue resolution and maximizing worker safety. and blind spots. operational efficiency. 16 TEC HN OLOGY SOLUTION S AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E C A S E S T U DY AUTOLOTO SETS NEW STANDARD FOR SAFETY AND EFFICIENCY A client in Malaysia was struggling with the limitations accuracy of LOTO executions. This is largely due to the of traditional lockout/tagout (LOTO) processes in their streamlined digital processes that replace cumbersome high-stakes construction and maintenance activities. The manual checks and reduce the time workers spend manual processes were prone to human error, bringing securing energy sources. Lastly, the client has seen a 300 risk of safety incidents, project delays and increased costs. percent return on investment, reflecting direct and indirect To enhance operational excellence, the client turned to savings through reduced downtime, fewer safety incidents CAI and our autoLOTO software, which includes a suite of and avoidance of regulatory fines. advanced features to overhaul LOTO processes, reduce human error and improve safety. Read the full case study. The implementation of autoLOTO has yielded substantial improvements in safety measures and operational efficiencies. There have been zero safety incidents in LOTO processes since the software was introduced. There has been up to an 88 percent increase in the speed and FEATURED TECHNOLOGIES 18 FEATURED TE CHN OLOG IE S AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E Our digital solutions combine cutting-edge technology with our industry expertise to transform processes, enabling organizations to work smarter and drive innovation. These are the more prominent tools we’re using to accelerate operational readiness and excellence. 1. DIGITAL TWIN management of assets. The tool integrates with existing can leverage real-time sensor data and facility schematics requiring oversight. These inefficiencies not only slow Enterprise Asset Management systems for seamless to ensure a faster, safer and more coordinated response. down maintenance but also introduce risks when energy Digital twin technology creates a virtual replica of a information flow. isolation plans fall out of sync with real-world conditions. physical space overlaid with real-time data from IoT Digital twin implementation can be done in a matter of sensors on the equipment. The tool transforms facility Maintenance planning and scheduling: Digital twin days with minimal disruption to operations, opening With autoLOTO, safety and maintenance personnel select management by enabling data-driven decision-making, streamlines maintenance planning by providing accurate, the door to benefits including enhanced collaboration, the equipment or system for energy isolation, and the enhancing collaboration and optimizing performance up-to-date visual data on equipment locations and improved decision-making, reduced downtime, lockout plan is automatically calculated in seconds. The across the entire organization. specifications and reduces equipment downtime through accelerated project timelines and reduced costs. process is fully guided and paperless, ensuring personnel more efficient scheduling and preventive maintenance. follow step-by-step digital instructions for lock placement, To start, our teams scan the facility using LiDAR and HD Integrating real-time sensor data with the model supports 2. AUTOLOTO zero energy confirmation and lock removal. RGB cameras to create high-fidelity 3D models with a level predictive maintenance strategies. of precision that far surpasses other types of renderings. AutoLOTO is an instant, intelligent lockout/tagout solution Every action is logged in real time, creating a full audit Typically, it takes a day to scan 150,000 square feet, Clash detection in capital projects: The exact model for maintenance and safety that replaces a slow, inefficient trail that not only ensures compliance but also accelerates or roughly one large building. Within days, the data is allows for more accurate clash detection compared to paper-based system. root cause analysis in case of an issue. When equipment processed and the facility operators can begin using the traditional models. With a digital twin, you can simulate is modified, updating the autoLOTO energy model is technology. changes and modifications before implementing them in The technology creates a fully digital, continuously quick, controlled and fully governed—ensuring lockout the real world. This allows project teams to test scenarios updated model of energy pathways within a facility. Instead procedures always reflect real facility conditions and The virtual replica eliminates the need for time-consuming and identify potential clashes. Also, by leveraging AI of relying on manual verification, autoLOTO maps every personnel are never working from outdated plans. manual inspections and enables remote inspections, and machine learning, digital twins can predict potential energy source, from the component level to the entire reducing travel costs and improving global collaboration. clashes based on historical data and patterns, allowing plant, into a dynamic digital twin. By automating and digitizing the energy isolation process, In addition, life sciences and mission critical facilities use a for proactive problem-solving. autoLOTO: digital twin to assist with: Using the old system, energy isolation requires reviewing Emergency response planning and simulation: Digital outdated engineering drawings, field-walking systems Reduces planning time from hours to seconds Asset management and inventory optimization: Precise twin technology provides first responders with a real-time, and double-checking every isolation point. This process Eliminates paper-based bottlenecks digital inventories improve tracking and maintenance interactive facility model, enabling pre-incident planning, can take hours to plan, and, if a piece of equipment is Ensures safety protocols are always up to date scheduling, and comprehensive digital records of route optimization and access to critical shutoff points modified, paper-based lockout plans must be updated and rigorously followed equipment history and performance enhance lifecycle before arriving on site. During an emergency, responders manually—a time-consuming task prone to delays and Leads to faster maintenance, improved compliance and a safer workforce 19 FEATURED TE CHN OLOG IE S AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E “CAI’s knowledge graph enables faster problem-solving, improves deviation tracking and enhances cross-functional collaboration between teams.” 3. TECHNICAL SUMMARIZATION Enhanced accuracy and compliance: The tool includes recurring issues, trace root causes and proactively Elimination of data silos and improved accessibility: intelligent guardrails for quality control. For accuracy, it address compliance risks. Unlike traditional databases, Organizations can instantly find relevant insights across AI APPLICATION ensures consistent quality across all technical summaries, knowledge graphs structure relationships between data quality, compliance, engineering and operations by reducing human error. To support compliance, it points, allowing AI to more accurately and meaningfully connecting previously disconnected data sources. This CAI’s AI technical summarization is purpose-built for incorporates regulatory requirements and company interpret information. enables seamless information flow across systems and regulated sectors, blending AI technology with deep standards into the summarization process and provides reduces manual data searches. industry experience to produce summaries that are swift, traceable workflows for improved auditability. The power of knowledge graphs comes from their ability precise, consistent and fully compliant. to connect information across different knowledge Acceleration of decision-making with contextualized Scalability and adaptability: The application can handle domains, provide context and relationships that may insights: By structuring and linking critical regulatory, The application uses a tailored AI framework with large volumes of technical documentation across multiple not be explicitly stated in documents, provide visual operational and research data, CAI’s knowledge graph capabilities such as structured document ingestion, projects and adapt to different document types and representation of data connections and improve the enables faster problem-solving, improves deviation classification and advanced summarization, to transform industry-specific requirements. It continuously improves performance of large language models by giving them tracking and enhances cross-functional collaboration complex technical documentation into accurate through machine learning and user feedback. structured relationship data. between teams. reports, accelerating decision-making and improving operational efficiency. 4. KNOWLEDGE GRAPHS/ CAI combines its knowledge graphs with retrieval- Reduction of time to insight and enhanced compliance: augmented generation or RAG. RAG is a technique that Knowledge graphs improve data retrieval efficiency by Facility managers turn to AI summarizations for IOQ UNIFIED INTELLIGENCE improves AI’s ability to retrieve precise, relevant information up to 30 percent, accelerating access to audit trails, summary reports, deviation summary reports, vendor from structured data. Unlike standard LLMs, which compliance reports and operational records—reducing evaluation summary reports and Factory Acceptance CAI’s knowledge graph and unified intelligence platform generate responses based solely on pre-trained data, time spent on manual review and regulatory submissions. Test evaluations. With its seamless, containerized empower organizations to harness their data’s full RAG dynamically pulls from live organizational knowledge, deployment, the Technical Summarization AI Application potential, driving informed decisions through enhanced enhancing accuracy, traceability and compliance. Smarter AI performance for enterprise use: By integrating is easy to implement and integrate into existing tools accessibility, contextual understanding and AI-powered structured knowledge into AI models, knowledge and workflows, leading to: analytics. Regulated industries use knowledge graphs to transfer graphs produce accurate results, reduce hallucinations data into insights in compliance monitoring, quality and provide explainable AI-driven insights—a critical Efficiency and time savings: The application automates A knowledge graph organizes and connects information management, research and development and technology requirement for regulated industries like pharmaceuticals, repetitive documentation tasks, freeing up valuable using nodes (concepts) and relationships, creating a transfer optimization, resulting in: life sciences and manufacturing. engineering time, and accelerates review processes by data structure that improves searchability, analytics providing consistent, well-structured summaries. The tool and decision-making. For example, in a pharmaceutical is capable of reducing summary report writing time by manufacturing setting, a knowledge graph can link up to 90 percent, completing what was a 40-hour task deviation reports, equipment maintenance records and in four hours. batch production data, allowing teams to quickly identify 20 FEATURED TE CHN OLOG IE S AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E “Positioned as the “future of qualification and validation,” CAI’s AI-augmented eVLM integrates cutting-edge AI technologies to enhance traditional validation processes.” 5. ELECTRONIC VALIDATION Streamlined efficiency: Automating manual validation GxPaaS: GxPaaS is a cloud-native GxP lifecycle platform Taking traditional eVLM solutions and adding artificial tasks reduces errors and trims overall validation project tailored for modern life sciences companies. Designed intelligence features enables: LIFECYCLE MANAGEMENT SYSTEM timelines by up to 30 percent. Centralized documentation for small- and medium-sized organizations, it is easy to (EVLM) IMPLEMENTATION improves accessibility and real-time collaboration. deploy, easy to use and cost effective. It also ensures Automated protocol generation and review for efficient GxP compliance without compromising on quality complex manufacturing processes CAI’s electronic validation lifecycle management system Enhanced compliance: eVLM improves overall quality or functionality. Risk-based sampling plan optimization for (eVLM) is a service that builds a comprehensive digital management and compliance adherence by increasing product testing and release solution for customers to streamline and optimize visibility and traceability of validation activities across the ValGenesis: A paperless validation lifecycle management Automated trend analysis for critical process validation processes in regulated industries. It digitizes organization and facilitating easier regulatory audits and system with modules for various validation activities, parameters and quality attributes documentation, automates workflows, enhances inspections with comprehensive reporting. Documentation including computer system validation and equipment Predictive modeling for process validation compliance management and provides real-time visibility errors are decreased by up to 50 percent, and compliance qualification. acceptance criteria throughout the entire validation lifecycle, from planning readiness improves by 40 percent. Automated change impact assessment for and protocol creation to execution and final reporting. Veeva Systems: Cloud-based software for the global life validated systems Operational excellence: The service standardizes sciences industry, including validation management tools eVLM empowers organizations to achieve operational validation processes across multiple sites or departments integrated with broader quality and regulatory offerings. Combined, these can cut validation timelines in half while readiness faster, ensuring robust compliance while and offers real-time monitoring of validation progress and improving compliance, help achieve zero critical deviations reducing costs and accelerating time-to-market through intelligent automation and data-driven insights. resource allocation. It can decrease validation-related 6. AI-ENABLED EVLM in a validation project through predictive analytics and costs by up to 25 percent. reduce validation-related costs by 25 percent in the first Positioned as the “future of qualification and validation,” year of implementation. Clients using CAI’s AI-enabled It is commonly used in pharmaceutical manufacturing CAI partners with eVLM solutions including: eVLM enjoy: CAI’s AI-augmented eVLM integrates cutting-edge AI process validation for new drug products, medical device technologies to enhance traditional validation processes. software validation for FDA compliance, biotechnology Kneat: A software platform for digitizing validation and Intelligent automation: AI-powered tools generate high- It leverages machine learning, natural language processing equipment qualification for GMP facilities, laboratory quality processes in regulated industries, with a focus on quality documentation in a fraction of the time, automate and predictive analytics to automate complex tasks, instrument qualification and method validation pharmaceutical and medical device sectors. complex data analysis for faster, more accurate results and generate data-driven insights and optimize validation and computer system validation for GxP-regulated trend detection and streamline decision-making. activities throughout the lifecycle, revolutionizing environments. CAI eVLM users benefit from: how organizations approach compliance and quality management. 21 FEATURED TE CHN OLOG IE S AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E Predictive insights: Machine learning models can identify potential issues before they impact production. Data- By leveraging AI-driven knowledge retrieval and intelligent document generation, CoPilot accelerates CQV workflows, CAI will continue to find ways to leverage AI driven trend analysis and predictive analytics optimize processes. And AI-powered predictive modeling and reduces errors and enhances execution excellence— expediting project timelines while improving client and technology to make processes quicker, simulations enhance risk management. satisfaction. more accurate and compliant, optimizing Continuous innovation: AI-augmented eVLM lets you Digital twin and smart turnover package: This concept performance for clients. stay ahead of industry trends with AI-driven process seamlessly integrates eVLM data into a high-fidelity improvements and benchmarking, adapt quickly 3D digital twin, so users can execute testing, retrieve to changing regulatory requirements with intelligent documentation and make informed decisions faster— compliance monitoring and unlock new levels of improving efficiency, compliance and operational operational excellence through AI-generated readiness. strategic insights. The package ensures that critical engineering, validation 7. OTHER TECHNOLOGIES and equipment-specific information is exactly where it’s needed—right alongside the virtual representation of the There are a number of other technologies in development physical asset. Instead of searching through disconnected that will further streamline work and maximize efficiency, libraries and turnover documents, operators, engineers creating value for clients. These include: and maintenance teams can instantly access validation records, test protocols and engineering data directly within CoPilot: CAI’s CoPilot is a knowledge graph-backed the digital twin model. generative AI assistant that integrates 30 years of CAI’s domain expertise with project-specific equipment, processes and client documentation. Unlike static templates, CoPilot dynamically connects and contextualizes information, ensuring project teams have real-time access to the right data at the right time. 22 TEC HN OLOGY SOLUTION S AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E C A S E S T U DY ACHIEVING FASTER TIMELINES AND COST SAVINGS THROUGH DIGITAL VALIDATION A Contract Development and Manufacturing Organization approval workflows while ensuring regulatory compliance. (CDMO) faced challenges in initiating validation projects As a result, CAI completed the project 57 percent under due to lack of established processes. CAI implemented competitor budgets, reduced document development Project Ready, powered by Kneat Gx, to address this costs by 25 percent and finished ahead of schedule. issue. The solution included a dedicated Kneat instance The project was initially set for January 2025 but with pre-validated workspace and CAI’s comprehensive was completed by early August 2024, demonstrating template library. CAI developed standardized, pre- CAI’s ability to efficiently manage complex projects approved content including SOPs, work instructions under tight constraints. and verification checklists for equipment validation. This approach streamlined document development and Read the full case study. THE FUTURE IS NOW 24 THE FUTURE IS N OW AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E STAYING AT THE FOREFRONT Regulated industries are being shaped by rapid By investing in AI, digital transformation and intelligent technological advancements, increasing regulatory automation, we ensure that our clients stay ahead of the complexity and an ever-growing demand for efficiency curve, leveraging cutting-edge technologies to accelerate OF INNOVATION and precision. At CAI, we are not just adapting to these time to market, reduce operational risks and drive changes—we are leading the way in how to respond. execution excellence. Here’s how we’re shaping the future: Integration of AI and machine learning Connecting siloed information for smarter Growing importance of data integrity Shifting toward outcome-based services in core processes operations and decisions and cybersecurity and measurable results CAI has invested in our own AI cloud and analytics Many organizations struggle with fragmented data across AI-driven solutions depend on high-quality data, and The industry is moving away from time-based consulting infrastructure to optimize how we run our business, quality, operations and engineering. CAI’s solutions, CAI ensures data integrity and security are built into and toward measurable, results-driven partnerships. CAI’s analyze risk and establish control strategies—the same powered by knowledge graphs and generative AI, unify every process. Through strong governance, automated technology-enabled approach delivers tangible benefits— strategies that help our clients solve their most complex disconnected information sources into a structured, validation and AI-assisted anomaly detection, we help accelerating time to market, reducing deviations and challenges. Beyond implementation, CAI is at the forefront accessible intelligence platform. This eliminates data silos, clients maintain compliance, reduce risk and improve driving continuous improvement in operational efficiency. of thought leadership regarding AI and regulations, leading improves collaboration and ensures decision-makers have the reliability of AI insights. We don’t just talk about industry forums, shaping best practices and influencing the right insights at the right times. security—we hold ourselves to the highest standards. CAI At CAI, innovation isn’t just about adopting new the evolving regulatory landscape. This ensures our clients has achieved ISO 27001 certification, demonstrating our technologies—it’s about transforming the way work gets remain aligned with emerging compliance expectations. commitment to world-class information security practices. done. As the landscape evolves, we will continue to push This ensures that our clients’ data remains secure, private the boundaries, ensuring our clients achieve excellence in and fully compliant with global regulatory requirements. execution every time. 25 THE FUTURE IS N OW AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E WHY YOU SHOULD START YOUR DIGITAL JOURNEY The future is now. Don’t get left behind. Early adoption of For companies in regulated industries like life sciences tech-enabled solutions will not only lead to accelerated and mission-critical facilities, adopting digital solutions is operational readiness and operational excellence, but it not just about innovation—it’s about ensuring business also provides companies with a competitive advantage priorities and compliance stay at the forefront. Whether going forward. you’re bringing a life-saving medicine to market, ensuring data access for critical operations or optimizing a facility As the pace of technology quickens, companies need a that powers industries—your mission is essential. partner who not only understands their business today but also ensures they are future-ready. We bridge the Success depends on aligning technology initiatives with gap between cutting-edge innovation that excites the business objectives, securing cross-functional buy- boardroom and practical solutions that deliver real, in, fostering a culture of continuous improvement and measurable performance. Whether it’s accelerating facility integrating new solutions seamlessly into daily operations. startup or optimizing long-term operations, we bring The right partner doesn’t just implement technology. They together the best of technology, industry expertise and ensure it delivers lasting impact while keeping you ahead execution excellence to keep you ahead of the curve. of regulatory demands and industry shifts. At CAI, we are your acceleration partner. We help bring your vision to reality through Operational Readiness and Operational Excellence, ensuring that your processes, equipment, people and culture are aligned for success. 26 THE FUTURE IS N OW AC C E LE RAT ING O P E RAT IO NA L RE A DINE S S A N D EXC EL L EN C E GETTING STARTED Ready to take the next step? CAI is here to be your trusted partner to accelerate operational readiness and excellence through technology-driven solutions tailored to your business needs. Let’s get started. Contact us today for a comprehensive assessment of your technological maturity and a customized roadmap for digital enablement, covering: Strategic implementation and change management: We guide you through every phase, ensuring seamless integration and team adoption. Operational readiness and excellence workshops: Gain expert insights and hands-on strategies to optimize performance. Continuous support and innovation: Stay current on the latest innovations with ongoing assessments and technology advancements tailored to your evolving needs. ARE YOU READY? CAI’s global headquarters are located at: 1060 N Capitol Ave, Suite 3-101 Indianapolis, IN 46204 Call us at (317) 271-6082 or contact us online.