About Quality System Services (QSYS)

At Quality System Services, we specialize in providing comprehensive quality management and microbiology solutions to the pharmaceutical, food, and healthcare industries. With years of expertise in Good Manufacturing Practices (GMP), regulatory compliance, and process optimization, we help businesses ensure the highest standards of product safety, quality, and efficiency.

Our services encompass a wide range of quality management solutions, including:

• Development and implementation of quality systems
• Microbiological testing and environmental monitoring
• Data management, reporting, and investigations
• Laboratory Information Management Systems (LIMS) consultation and setup
• Auditing and regulatory compliance support

We work closely with clients to identify gaps in their processes and develop customized solutions that meet industry regulations and best practices. Whether you need assistance in managing batch records, sample tracking, trending results, or writing detailed investigations, we provide the tools and expertise to ensure your quality systems are robust and efficient.

At QSYS, our commitment is to deliver precise, reliable, and actionable insights that improve product quality, streamline processes, and support compliance with regulatory standards.

Partner with us to enhance the quality and integrity of your operations.

At Quality System Services (QSYS), we provide end-to-end quality and microbiology solutions tailored to the needs of the pharmaceutical, food, and healthcare industries. Our team of experts ensures your operations are compliant, efficient, and aligned with global regulatory standards.

We help you build and maintain robust quality systems that comply with FDA, EMA, and ICH guidelines. Our services include:

• Quality System Development & Implementation
   
• Batch Record Design and Review
   
• Deviations, CAPA, and Change Control Support
   
• GMP Gap Assessments & SOP Authoring
   

Ensure microbial control in your cleanrooms and production areas with expert support in:

• Routine Environmental Monitoring (EM) Programs
   
• Microbiological Testing and Trending
   
• EM Excursion Investigations
   
• Aseptic Technique Training & Risk Assessments
   
• EMPQ and Recovery Studies (Air, Surfaces, Personnel)
   

Leverage digital tools to streamline your lab operations and compliance:

• LIMS Setup and Configuration
   
• Sample Tracking and Chain of Custody
   
• Trending Reports and Data Visualization
   
• Electronic Batch Record Integration
   
• Certificate of Analysis (CoA) Automation
   

We offer comprehensive support in cleaning program development to ensure contamination control:

• Cleaning Validation Protocols (TOC, Microbial, Visual)
   
• Cleaning Verification and Hold Time Studies
   
• Worst-case Product/Soil Selection
   
• Risk-Based Sampling Strategy Design
   
• Equipment Grouping and Lifecycle Documentation
   

Prepare for inspections and meet global standards with confidence:

• Internal GMP Audits and Mock Inspections
   
• Regulatory Readiness (FDA, EMA, WHO, etc.)
   
• Vendor Qualification and Auditing
   
• Data Integrity Reviews
   
• Training and Documentation Support
   

• Deep industry expertise in regulated environments
   
• Practical, efficient, and compliant solutions
   
• Flexible on-site and remote consulting options
   
• Commitment to delivering results you can trust
   

💬 Contact us today to learn how QSYS can help optimize your quality systems and ensure compliance across every process.