"ValidAId minimizes repetitive work, allowing us to focus on critical tasks such as running and monitoring validation tests, analyzing results, and solving issues. It equips our consultants with a tailored AI assistant that boosts both efficiency and accuracy in their daily workflow.”
- Liesbeth Fleerakkers, SMO Director Validation Services at Agidens

Executive summary

Context

Agidens is an international company with over 500 employees that specializes in industrial process automation, software, and validation across various industries like Fine Chemicals, Life Sciences, Food & Beverage, and Energy. Their validation consultants are responsible for ensuring pharmaceutical equipment and production lines perform according to prescribed functionalities. This requires extensive documentation, including User Requirement Specifications (URS), test protocols, and work instructions based on complex regulations, guidelines, standards, and manuals. 

Goal of the project

Transform the highly manual, research-intensive validation process by leveraging Generative AI to enhance competitive advantage and operational efficiency. The objective is to achieve measurable time savings in creating essential compliance documentation while maintaining the rigorous standards required in pharmaceutical validation. This also enables consultants to focus on high-value activities.

Solution

Starting from comprehensive workshops and an analysis of their current validation challenges, Superlinear collaborated with Agidens to develop ValidAId, a proprietary AI-powered assistant embedded directly into consultant workflows. The final solution combines Retrieval-Augmented Generation (RAG) with a comprehensive knowledge base of validated sources, integrated in Microsoft Word to enable rapid creation of high-quality validation documents while ensuring full traceability and compliance with industry standards.

Case study

Challenge

Validating pharmaceutical equipment and production lines is currently a highly manual and time-consuming process, with regulatory requirements becoming increasingly complex and validation timelines under increasing pressure. The current validation process demands extensive manual research into customer standards, legislation, industry guidelines, and reference materials. Validation consultants must synthesize information from device manuals, software documentation, SOPs, work instructions, and regulatory frameworks to create comprehensive test protocols and URS documents.

The manual nature of this process creates several significant challenges that directly impact operational efficiency and competitive positioning.

• The project onboarding phase and creation of testing protocols are the most time-consuming steps, often requiring days of research for each validation project. 

• Manual analysis of large quantities of documentation is prone to human errors and biases, potentially compromising compliance outcomes. 

• Furthermore, consultants spend valuable time on repetitive documentation tasks rather than high-impact validation activities that require their specialized expertise.

With validation timelines under increasing pressure from clients, Agidens recognized the urgent need for a technological solution that could maintain its high-quality standards while dramatically improving efficiency and competitive advantage.

The AI journey: From concept to competitive advantage

Agidens' AI journey shows how strategic AI implementation can transform highly regulated industries. Their partnership with Superlinear evolved through distinct phases, each building upon the previous to create a robust, production-ready solution:

Phase 1 - Proof of concept

Superlinear started the project with a high-impact prototype, focusing on assessing technical feasibility and identifying quick wins. The PoC demonstrated the potential for AI to generate IOPQ protocols from URS documents, providing a testable foundation that allowed stakeholders to experience the solution's capabilities firsthand and prove the added value of AI in the validation process.

Phase 2: Define and design

Building on PoC learnings and end-user feedback, Superlinear organized workshops with Agidens' validation consulting team to further understand their current workflows, assess end-user needs through ideation sessions, and design an MVP solution focusing on integration and user adoption. These sessions focused on mapping the complex relationships between different types of validation documents and regulatory requirements while identifying specific pain points in their validation process.

Phase 3: Minimum viable product development

Superlinear integrated the application into Agidens' daily operations, incorporating features that allowed end-users to interact directly with the AI through phased releases. The MVP included core knowledge base functionality, template adaptation capabilities, and an intuitive user interface enabling consultants to influence AI outputs through natural language interactions. Rigorous A/B testing across 13 different validation tasks provided measurable evidence of time savings and quality improvements.

Phase 4: Sustainable solution

The final phase focused on scalability, maintainability, and comprehensive user training. Superlinear implemented monitoring solutions with feedback mechanisms, enabling continuous improvement of the AI's performance based on real-world usage and consultant feedback. The solution was architected to scale from 7 daily users to 150 pilot users, with infrastructure designed to support organization-wide adoption.

Competitive differentiation: ValidAId vs. Generic AI Tools

ValidAId's industry-specific design creates substantial competitive advantages over generic AI solutions:

The crucial components of ValidAId

1. Integrated architecture

ValidAId seamlessly integrates into consultant workflows through a Microsoft Word Add-in, enabling direct interaction with validation documents while maintaining familiar working environments. SharePoint connectivity ensures automatic access to project documents, while the solution's architecture supports both paper-based and paperless validation processes through flexible user interfaces.

2. Knowledge base integration with Retrieval-Augmented Generation

ValidAId incorporates crucial validation resources, including device manuals, software documentation, SOPs, work instructions, and OQ/IQ/PQ templates into a searchable, AI-enhanced knowledge base. The system uses advanced Retrieval-Augmented Generation with Azure AI Search to ensure all responses are grounded in validated, industry-specific sources. This approach prevents the hallucination issues common in generic AI tools while ensuring compliance with pharmaceutical industry standards.

3. Intelligent testing protocol generation with full traceability

The AI compiles comprehensive test protocols enriched with complete traceability information, enabling consultants to verify generated content and adjust specific details without regenerating entire documents. This efficient review process significantly reduces errors while improving overall document quality. Each generated test includes procedure steps, expected results, and direct references to source materials with specific page numbers for validation.

4. Flexible, secure, and compliant across work environments

The solution guarantees full data isolation between clients while ensuring 100% traceability. All AI-generated content includes direct references with page numbers, allowing consultants to verify recommendations against source documents easily. ValidAId adapts to both paper-based and digital workflows. In Microsoft Word, consultants access contextual AI support directly within documents, while a web plugin and overlay UI enable smooth interaction with digital validation systems. This flexibility allows ValidAId to support diverse project types and client requirements.

Measurable impact and results

Based on thorough analysis and user feedback after initial deployment, ValidAId has delivered transformative results for Agidens' validation operations:

• User satisfaction rate of 81.6%, demonstrating the effectiveness and acceptance of the AI-powered solution

• Significant reduction in manual documentation effort, allowing consultants to focus on high-value validation activities

• Maintained 100% traceability for all generated documentation, ensuring full compliance with pharmaceutical industry standards

• Sub-minute response times for document generation, dramatically accelerating the validation process

The solution has successfully differentiated ValidAId from generic AI tools by providing project-specific responses using validated sources, offering predefined workflows tailored to validation tasks, and delivering industry-specific language and prompts that understand the nuanced requirements of pharmaceutical validation.

Future vision and strategic roadmap

With the successful deployment of ValidAId, Agidens has established a significant competitive advantage in the validation services market while setting the foundation for broader AI-powered transformation:

Immediate expansion:

• 150-user pilot phase with comprehensive monitoring and feedback collection

• Infrastructure scaling from the current 3-instance to a 5-instance architecture supporting increased usage

• Enhanced monitoring solutions with automated evaluation and continuous improvement mechanisms

Strategic development roadmap:

• GenAI Agent Evolution: Expanding from Retrieval-Augmented Generation to intelligent agent capabilities for complex query handling, including automated traceability matrix generation and multi-step validation workflows

• Additional Tool Development: Report generation automation, template generation capabilities, and batch test generation for improved efficiency

• Organizational Adoption Target: 75% consultant adoption by the end of 2025, with a positive ROI demonstration

Technology enhancement pipeline:

• Advanced query processing for complex validation scenarios requiring multi-document synthesis

• Automated traceability matrix creation linking URS requirements to test protocols

• Integration expansion with additional validation platforms and regulatory frameworks

• Knowledge base evolution to cover emerging pharmaceutical technologies and evolving compliance requirements

Market positioning and growth: Current development efforts focus on enhancing the AI's understanding of complex regulatory frameworks while expanding capabilities to cover emerging pharmaceutical technologies. The team is exploring integration with additional validation tools and platforms to create a comprehensive AI-powered validation ecosystem that positions Agidens as the technology leader in validation consulting services.

"ValidAId represents the future of validation consulting, where artificial intelligence amplifies human expertise rather than replacing it, enabling our consultants to deliver unprecedented value to our pharmaceutical clients while maintaining the highest standards of compliance and quality."
- Philip De Keulenaer, Chief Technology Officer at Agidens

The success of ValidAId demonstrates the transformative potential of industry-specific AI applications in highly regulated environments, paving the way for similar innovations across Agidens' broader automation and process engineering services while establishing a new standard for AI-powered validation consulting in the pharmaceutical industry.