LIFE SCIENCES

Life sciences engineering and automation solutions are the facility, utility, controls, and compliance-ready systems that enable safe, repeatable operations in FDA-regulated and cGMP environments. Hallam-ICS designs and integrates engineering, process control, and commissioning/validation to safeguard product quality, patient safety, and data integrity.

cGMP facilities commonly require MEP and process engineering for cleanrooms and controlled environments, reliable process/central utilities, and hazard-aware design for regulated and high-risk areas. Hallam-ICS engineers deliver designs that are buildable, maintainable, and ready for qualification.

Commissioning verifies systems operate as intended. Validation and qualification provide documented evidence that equipment, software, utilities, and instruments are fit for use and deliver repeatable performance in GMP environments. Hallam-ICS Cx/V experts plan, document, and execute testing to support compliant startup.

21 CFR Part 11 compliant process control systems support regulated electronic records and signatures (when applicable) through controlled access, traceability, and procedures that protect data integrity. Hallam-ICS designs automation solutions with compliance expectations in mind and aligns documentation for regulated environments.

An EMS monitors environmental conditions that impact product quality—such as temperature, humidity, pressure differentials, and other critical parameters—and documents alarms and trends for investigations and audits. Hallam-ICS integrates EMS platforms with facility utilities and reporting to improve visibility and response.

Batch/S88 is a standard that structures batch control using standardized recipes, phases, and equipment models—making automation easier to validate, maintain, and scale. Hallam-ICS implements batch control strategies and documentation that support reliable GMP production.

PlantPAx is Rockwell Automation’s process control architecture used to standardize PLC/HMI/SCADA development and lifecycle management. Hallam-ICS supports PlantPAx-based solutions for life sciences facilities that want a consistent, supportable platform across multiple lines or sites.

A Main Instrument Vendor (MIV) centralizes instrument specification, procurement, receiving, bench testing, installation coordination, and calibration—so instrumentation doesn’t become the critical path. Hallam-ICS can serve as MIV and develop engineered turnover packages to support qualification and turnover.

An ETOP is the documentation package that supports turnover and validation—typically including device data, calibration records, loop checks, as-builts, and traceability to requirements. Hallam-ICS uses ETOP development to reduce rework and speed up commissioning and qualification.

Hallam-ICS supports FDA-regulated and cGMP facilities, GMP validation areas and systems, biosafety and cleanroom R&D facilities, hazardous locations (including combustible dust), and central utility and process utility systems—bringing engineering, controls, and compliance support under one team.

Hallam-ICS reduces risk by aligning requirements early, building documentation and traceability into design, and planning testing so commissioning evidence supports qualification. Our teams coordinate engineering, automation, and Cx/V to avoid late-stage changes, duplicate testing, and startup delays.

Yes. Hallam-ICS has supported life sciences clients for 35+ years in GxP settings and delivers programs across pharmaceutical, biologic, and medical device operations. We bring practical experience that helps teams move faster without compromising compliance.

If you share your process type, regulatory expectations (GMP/GxP), and project timeline, the Hallam-ICS life sciences team can recommend the right engineering, automation, and Cx/V scope—then provide a clear path to budget and schedule.