Life Sciences

LSI’s engineering team delivers robust automation and control systems, advanced data solutions, and end-to-end validation services. We help pharmaceutical, biotech, and medical device companies optimize production, ensure compliance, and accelerate innovation with confidence.

• Pharmaceutical Manufacturing Automation: Implementing systems that ensure consistent product quality and regulatory compliance in pharmaceutical manufacturing. Our solutions automate various stages of production to maintain high standards and meet regulatory requirements.
• Biotechnology Process Control: Designing and integrating advanced control systems for specialized bioprocessing applications, including the Production of Biopharmaceuticals, Single-Use Bioprocessing Systems, and Continuous Bioprocessing.
• Medical Device Assembly Automation: Developing automated solutions for the precision assembly and testing of medical devices.
• Life Sciences Validation—CSA‑Driven, Risk‑Based: Assurance where it matters most. LSI delivers a modern, pragmatic validation practice aligned with FDA’s Computer Software Assurance (CSA) principles. We embed validation into automation, MES, and data solutions, so you gain faster releases, stronger data integrity, and audit‑ready traceability—without unnecessary paperwork.

• • • CSA-aligned risk strategy that prioritizes patient safety, product quality, and data integrity over rote testing.
    • Integrated validation across PLC/DCS/SCADA, MES/EBR, historians, and data pipelines—assurance built into every layer.
    • Lean, digital documentation with e‑approvals and end‑to‑end traceability from URS to release.
    • Operational intelligence—contextualized data that supports investigations, deviation management, and continuous improvement.

• System Design & Integration: Comprehensive system design, including instrumentation, system networks, mechanical, piping, and skid design.
• Process Controls & Automation: Design, implementation, and integration of DCS, PLC, HMI, SCADA systems, and MES.
• Data Management: SCADA and MES integration, EBR (Electronic Batch Record) deployment, data acquisition, analysis, and historians for process analytics.
• Digital Transformation: Services to modernize and optimize operations through the integration of advanced digital technologies.
• Validation Services:

          CSA Risk Assessment & Strategy

• • • Product and process impact analysis
    • Automated vs. manual action classification
    • Critical thinking‑based test strategy and scope
    • Validation plans tailored to system risk and complexity

          Validation Lifecycle (Streamlined)

• • • Requirements definition: URS, FRS, and risk‑mapped specifications
    • Design reviews and supplier assessments
    • CSA‑aligned verification: scripted and unscripted testing
    • We support IQ/OQ authoring and execution, and provide PQ authoring support with execution typically performed by the client
    • Digital traceability (requirements → risks → tests → evidence)

          MES & Digital System Validation

• • • MES/EBR (recipe/batch, workflows, and review by exception)
    • SCADA and historians, data collection, and contextualization
    • Data integrity controls (Part 11, audit trails, and user/role security)
    • Interfaces: OT/IT, LIMS, ERP, and data lake integrations

         Change Control & Continuous Compliance

• • • Change impact assessment and regression strategy
    • Periodic review and risk‑based revalidation
    • Audit preparation and support
    • Package remediation and modernization (CSV → CSA)

• Predictive Maintenance: Implementation of systems to forecast equipment failures and optimize maintenance schedules.
• Cybersecurity: Measures to protect industrial control systems from cyber threats.
• Panel & Skid Design: In-house UL-certified panel shops across North America and Asia deliver turnkey skid systems, robot cells, and full mechanical designs.
• Advanced Testing Facilities: State-of-the-art facilities for system testing and validation.

Single-Use Fermentor Upgrade

This project focused on upgrading an integral Single-Use Fermentor (S.U.F.) to reduce reliance on proprietary software and enhance process efficiency. Key aspects included:

• Controller Replacement: Replaced the pre-existing proprietary controller and DeltaV interface, with a new Allen Bradley PLC and connected to the plant supervisory PLC and iFix SCADA interface.
• Enhanced Process Control: Added functionality for improved control of fermentation loops in the S.U.F.
• Additional Equipment: Installed additional peristaltic dosing pumps for pH control and new I/P pressure regulator valves for dissolved oxygen (DO) control.
• Temperature Control: Converted the S.U.F. to use a dual loop heat exchanger for precise temperature control.
• Validation Support: The upgraded system was validated to confirm that the new control architecture, enhanced process‑control functions, and added equipment operate reliably and consistently as intended, meeting all applicable user, process, and cGMP requirements.

Plant Utilities Upgrade

This project involved a comprehensive update of the Water For Injection (WFI), steam, chilled water, clean steam, and condensate systems across the entire plant. Key aspects included:

• Controller Migration: Transitioned from GE Fanuc PAC controllers to Allen Bradley controllers.
• Integration: Integrated multiple vendor skids with the new plant supervisory controller and SCADA system (iFix).
• Logic Update: Recontrolled outdated logic using S88 standards to ensure modern, efficient operations.
• Supervisory Control: Implemented supervisory control for new plant steam and WFI skids, enabling load balancing and redundancy.
• Validation Support: The upgraded utility systems were individually validated (IQ/OQ) to demonstrate that the implemented control enhancements perform as intended and ensure compliant, reliable operation across all plant utility processes.

Clean In Place (CIP) Skid Upgrade

This project involved upgrading the Clean In Place (CIP) system for a Contract Development and Manufacturing Organization (CDMO) from an end-of-life controller and PanelView interface to a modern Allen Bradley PLC with iFix. Key aspects included:

• System Upgrade: Transitioned the CIP system to a modern Allen Bradley PLC with iFix.
• Phased Validation Approach: Developed and implemented a phased validation approach due to the CIP skid’s impact on every process in the plant.
• Validation Support: The upgraded system was validated to confirm that the phased qualification approach ensured all hardware, software, and functional capabilities performed as intended and supported compliant, reliable operation across all impacted processes.

Waste Neutralization System

This project involved implementing a new plant waste neutralization system to process purification and fermentation waste before release to the city. Key aspects included:

• System Implementation: Installed a dual sump and tank system to enable “semi-continuous batch” neutralization.
• Automated Sampling: Implemented automated pH sampling with 2oo3 voting for quality data.
• Data Historization: Established data historization for city reporting purposes.
• Validation Support: The new system was validated to ensure that the neutralization process, automated sampling, and data historization functions perform as intended for their identified high‑risk functions while maintaining compliance with applicable process and reporting requirements.