SERVICES
Quality Control & Lab Operational Support
PTSI supports the design, qualification, and operational readiness of Quality Control (QC) laboratories to ensure they are compliant, efficient, and aligned with manufacturing timelines. Our biopharmaceutical Subject Matter Experts integrate environmental control, analytical capability, and digital systems to deliver fully operational, inspection-ready labs.
Environmental Monitoring Performance Qualification (EMPQ)
PTSI delivers customized Environmental Monitoring Performance Qualification (EMPQ) programs designed to support manufacturing readiness, regulatory compliance, and long-term product quality. Our experienced biopharma Subject Matter Experts partner with clients to implement risk-based strategies aligned with global GMP expectations.
EMPQ services include:
• Disinfectant Efficacy Testing (DET)
• Environmental Monitoring (EM) Baseline Studies
• Contamination Risk Assessments
• Development of Contamination Control Strategies (CCS)
• SOP development for Gowning, Cleaning & Disinfection, and Environmental
Analytical Methods & Product Characterization
We deliver comprehensive analytical solutions to ensure reliable, defensible data and robust product control strategies.
Our capabilities include:
• Analytical method development and optimization
• Method transfer, qualification, and validation
• Product characterization and comparability support
• Development of analytical control strategies
• Stability and release testing strategy support
Our tailored solutions help ensure data integrity, regulatory compliance, and confidence in product quality.
Laboratory Systems & LIMS Implementation
A modern QC laboratory requires structured digital infrastructure. PTSI specializes in implementing and optimizing Laboratory Information Management Systems (LIMS) to enhance data integrity and operational efficiency.
Our Approach Includes:
• Assessment of existing workflows and data processes
• LIMS configuration and customization
• Data integrity and audit trail alignment
• User training and change management
• Regulatory compliance integration
PTSI support enables laboratories to achieve improved traceability, streamlined workflows, and sustainable compliance. PTSI ensures QC laboratories are not only built correctly but also operate efficiently, compliantly, and confidently under regulatory scrutiny.