How SRG Delivered a Successful Biotech Lab Relocation

Migration of Multiple Facilities: Relocate laboratory equipment, infrastructure, and workflows from multiple properties to a new centralized campus using a strict change control process. 

Full-Scope Validation: Ensure all equipment, processes, and systems meet regulatory standards (e.g., FDA, GMP, ISO) post-migration. 

Contingent Workforce Management: Deploy a specialized temporary workforce to manage the project, minimizing the need to reallocate internal staff. 

Cost Efficiency: Avoid purchasing new support equipment by validating and repurposing existing assets, using rental equipment, and reducing labor costs by leveraging SRG’s contingent workforce. 

Due Diligence: Conduct thorough assessments to ensure compliance, safety, and operational continuity. 

Timeline: 9-12 months. 

Coordinating the migration of sensitive laboratory equipment without disrupting research timelines. 

Ensuring full validation and regulatory compliance at each site. 

Managing a large-scale project across multiple properties with differing infrastructure. 

Avoiding the cost and downtime associated with purchasing new equipment. 

Preventing the diversion of internal staff from ongoing projects, which could delay other company initiatives. 

Asset Inventory: Cataloged the laboratory equipment, including high-value assets like laminar flow hoods, sterility isolators, and multiple incubators. 

Regulatory Mapping: Identified compliance requirements for each facility, aligning with FDA, GMP, and ISO standards. 

Risk Assessment: Evaluated risks related to equipment relocation, downtime, and validation failures, including potential hazards, to create a mitigation strategy. 

Stakeholder Engagement: Collaborated with leadership, lab managers, and quality assurance teams to define priorities and timelines. This collaboration allowed the team to be as active in the process as they chose while assuring all project milestones were met. 

Defined roles for SRG’s project managers, validation specialists, and contingent workforce. 

Budgeted projections and cost-saving strategies, such as equipment refurbishment instead of replacement. 

Developed a phased migration plan, prioritizing critical equipment and minimizing operational downtime. 

Change Control: A formal change control process was initiated and followed throughout the project, including impact assessments, risk analyses, approvals, documentation, and post-move verification. 

Equipment Assessment, Cleaning, and Refurbishment: Equipment was reviewed for maintenance, calibration, qualification, and usage history. Decontamination and cleaning procedures were performed before transport, and functionality tests were conducted to identify reusable assets. 

Logistics and Transport: Coordinated specialized transport with environmental controls (temperature, humidity) to protect sensitive assets. 

Workforce Needs: Deployed trained teams for decommissioning, transport, installation, and validation, working closely with equipment vendors. 

Installation and Setup: Installed equipment and commissioned new units while optimizing layouts based on lean workflow principles. 

Equipment Validation and Requalification: Conducted Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for all critical equipment. 

Process Validation: Validated laboratory workflows, including sample handling, testing protocols, and data management systems. 

Calibration: Ensured all measuring equipment was calibrated and traceable to national standards. 

Documentation: Generated full validation reports to support accessibility and audit readiness. 

Updated Equipment Records: All move-related activities and testing results will be documented in the equipment's maintenance history.  

Formal documentation was generated for each piece of equipment in its new location.  

Regulatory Compliance: Maintained adherence to GMP/GxP standards through validation protocols. 

Workforce Sourcing: Recruited and trained personnel with expertise in biotech lab operations, reducing the need to pull internal staff from critical research projects. 

Scalability: Adjusted headcount during validation peaks without incurring long-term labor costs. 

Equipment Reuse: Refurbishment eliminated approximately $1 million in fit-out costs. 

Labor Optimization: Reduced internal labor costs by 30% by deploying a contingent team. 

Operational Efficiency:  Improved turnaround times by 20% and lowered recurring costs in the new space. 
 

Successful Migration: All assets will be relocated to the new campus without significant downtime or equipment damage. 

Regulatory Compliance: Full validation ensured 100% compliance with FDA, GMP, and ISO standards, passing all subsequent audits. 

Minimal Disruption: Internal staff continued core research activities, maintaining project timelines and revenue streams. 

Operational Continuity: This solution better manages business risk with no significant research downtime or loss of data integrity occurring during the transition, including no disruption to production, R&D, or QA timelines.