Services

Factory Acceptance Test (FAT) Support: Ensuring Equipment Readiness and Project Success

Choosing Intelion for your Factory Acceptance Test (FAT) support means partnering with a team dedicated to meticulous oversight and proactive problem-solving, safeguarding your investment and project timelines. The FAT is a critical milestone, and our comprehensive support is designed to de-risk this phase significantly, ensuring your equipment, systems, and software are fully verified against specifications before they leave the vendor’s site.

Why Intelion for FAT Support?

• End-to-End Lifecycle Management: Our involvement extends beyond mere execution. We begin with Strategic Pre-FAT Activities, including robust protocol development, vendor coordination, and thorough readiness reviews to identify and mitigate potential issues proactively.

• Expert On-Site Execution: During FAT Execution, our experienced engineers provide diligent oversight, manage test procedures, meticulously document results, and facilitate efficient deviation investigation and resolution. We act as your expert eyes and ears, ensuring adherence to your User Requirement Specifications (URS) and design qualifications.
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• Comprehensive Post-FAT Closure: We ensure a smooth transition with detailed Post-FAT Activities, including the compilation of comprehensive reports, verification of punch list closures, and ensuring all documentation is complete and accurate for the subsequent stages of your project.
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‍• Reduced Project Risks & Costs: By identifying and resolving issues at the vendor's facility, Intelion helps prevent costly delays, rework, and complications during on-site installation, commissioning, and qualification. Our rigorous approach ensures that equipment arrives fit for purpose, accelerating your overall project schedule.
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‍• Deep Pharmaceutical Expertise: Our team understands the nuances of pharmaceutical equipment and regulatory expectations, bringing a level of scrutiny and insight that is invaluable during FATs for complex systems.

With Intelion, your FAT is not just a checkbox exercise; it's a strategically managed process that lays a solid foundation for successful site activities and long-term operational reliability.

Execution and Oversight:
‍Ensuring Quality Every Step of the Way

Expert On-Site Supervision: Our experienced team provides on-site guidance, ensuring adherence to protocols, resolving issues in real-time, and fostering seamless communication between vendors and your CQV team.

Comprehensive Testing and Inspections: We conduct rigorous testing and inspections, guaranteeing compliance with industry standards and verifying optimal equipment functionality.

Proactive Project Management: We provide proactive project management support, identifying and resolving potential roadblocks to keep your FAT on track and within budget.

Comprehensive Validation Services: Ensuring Compliance, Quality, and Efficiency

Intelion offers a holistic suite of Validation Services, meticulously designed to navigate the complexities of regulatory compliance and ensure your pharmaceutical facilities, utilities, equipment, and processes meet the highest standards of quality and performance. We partner with you through every stage of the validation lifecycle, transforming a regulatory necessity into a value-driven process that enhances operational excellence.

Why Intelion for Comprehensive Validation Services?

• Full Lifecycle Validation Expertise: Our seasoned CQV (Commissioning, Qualification, and Validation) engineers possess in-depth knowledge of the entire validation continuum. This includes developing robust User Requirement Specifications (URS), executing Design Qualifications (DQ), supporting Factory Acceptance Tests (FAT), and conducting thorough on-site Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
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• Integrated Multidisciplinary Approach: What truly sets Intelion apart is our integrated team of experts. Our Electrical Engineers ensure equipment power and control systems are robustly qualified. Our Automation Specialists meticulously validate computerized systems, control logic, and data integrity. Our QA Professionals embed quality oversight throughout, ensuring all activities and documentation stand up to regulatory scrutiny. This synergy eliminates silos and ensures a cohesive, efficient validation outcome.
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• Regulatory Adherence and Best Practices: We are well-versed in global regulatory expectations (FDA, EMA, GxP) and apply current industry best practices, including risk-based validation methodologies. This ensures your validation efforts are not only compliant but also efficient and scientifically sound.

• Proactive Problem Solving & Efficiency: We don't just execute protocols; we anticipate challenges and identify opportunities for process optimization. Our goal is to streamline your validation efforts, reducing timelines and resource burdens while maintaining the highest level of compliance and quality assurance.

• Partnership for Long-Term Success: Choosing Intelion means gaining a partner committed to your success. We provide clear documentation, facilitate knowledge transfer, and help establish a state of sustained compliance, ultimately contributing to faster product-to-market timelines and operational excellence.

With Intelion, you achieve more than just validation; you gain confidence in your processes, systems, and compliance posture.

Pharmaceutical Project Management: Delivering Complex Projects with Precision and Clarity

In the demanding landscape of pharmaceutical engineering, effective Project Management is paramount to success. Intelion’s Project Management services are tailored to the unique challenges of this sector, providing the strategic oversight, rigorous control, and clear communication needed to deliver complex projects on time, within budget, and to the highest quality and regulatory standards.

Why Intelion for Pharmaceutical Project Management?

• Specialized Industry Expertise: Our Project Managers (PMs) are not just generic managers; they are professionals with significant experience specifically within pharmaceutical engineering and validation projects. They understand the critical path, regulatory implications, and technical complexities inherent in your initiatives.

• Proactive & Comprehensive Planning: We believe in front-loading success. Our PMs excel in detailed project planning, scope definition, risk assessment, and mitigation strategies. This proactive approach minimizes surprises and provides a clear roadmap for all stakeholders.

• Rigorous Execution & Control: Intelion PMs ensure disciplined execution through robust progress tracking, budget management, change control processes, and resource optimization. They foster accountability and maintain a keen focus on achieving critical milestones.

• Transparent Stakeholder Communication: We prioritize clear, consistent, and transparent communication with all project stakeholders. Our PMs ensure that you are always informed of project status, potential challenges, and decision points, fostering a collaborative environment.

• Adaptable & Modern Methodologies: While adhering to proven project management principles, our PMs are also tech-savvy and adaptable. They leverage appropriate modern tools and methodologies to enhance efficiency, improve collaboration, and provide real-time insights, ensuring your project benefits from the latest best practices.

• Focus on Quality and Compliance: Woven into every aspect of our project management approach is an unwavering commitment to quality and regulatory compliance, ensuring that project deliverables meet all necessary pharmaceutical standards.

Partnering with Intelion for Project Management means entrusting your critical pharmaceutical engineering projects to a team that combines deep industry knowledge with disciplined execution and a commitment to your strategic objectives.

Post-FAT:
‍Seamless Closeout and Continuous Improvement

Punch List Management: We take the hassle out of punch list management, handling documentation, coordinating with vendors, and ensuring timely resolution of all outstanding items.

Post-FAT Analysis: We conduct in-depth post-FAT analysis, generating detailed reports and developing strategies to optimize future FATs.

AI/ML Validation Platform: Pioneering the Future of Pharmaceutical Validation (Coming Soon)

Intelion is on the cusp of transforming the landscape of pharmaceutical validation with the development of an innovative, AI and Machine Learning-powered SaaS platform. While we are preparing for its full unveiling, we are excited to share our vision for a future where validation processes are significantly more intelligent, efficient, and data-rich.

Why This Matters for You (The Vision):

• A Paradigm Shift in Efficiency: Imagine a validation world where time-consuming manual checks and documentation reviews are dramatically streamlined. Our platform is being engineered to leverage the power of AI and computer vision to automate critical verification tasks, freeing up your valuable human expertise for higher-value activities and accelerating project timelines.

• Unprecedented Data Integrity and Traceability: This next-generation platform aims to set new standards for data integrity and end-to-end traceability. By harnessing AI, we envision a system that not only captures data flawlessly but also provides powerful analytics and insights, making audit readiness and compliance reporting more robust and intuitive than ever before.

• Driving Innovation with Confidence: Intelion is committed to empowering pharmaceutical innovation. This platform is a testament to that commitment, designed to provide a smarter, faster, and more reliable validation framework. This will allow companies to bring life-changing therapies to market with greater speed and assurance, backed by validation processes of the highest calibre.

• Shaped by Expertise, Built for the Future: Developed by a team with deep roots in pharmaceutical engineering and validation, our AI/ML platform is being meticulously trained and designed to meet the stringent demands of the industry. It represents Intelion’s dedication to not just participating in the future of validation, but actively building it.

Stay tuned as Intelion prepares to introduce a solution that promises to redefine efficiency, reliability, and insight in pharmaceutical validation. We are excited about the potential to help you achieve unparalleled operational excellence.