Validation
We boast a track record of excellence in building validation programs from scratch and shepherding our clients through the FDA approval process until their products are cleared.
Facility Validation
Specializing in comprehensive facility validation, we conduct meticulous P&ID diagram reviews, Water system, precise HVAC implementation, and meticulous clean room validation adhering to ISO standards. Our services guarantee regulatory compliance and uphold operational excellence within your facilities.
Process and Test Method Validation
Our team ensures that your manufacturing processes consistently produce high-quality products meeting specified standards through meticulous process validation. Concurrently, our test method validation confirms the suitability of pharmaceutical testing methods for their intended use, ensuring reliability and accuracy in quality assurance.
Lab Instruments and Manufacturing Equipments
Ensuring Precision Validation for Manufacturing Equipment and Analytical Lab Instruments. Our service is committed to meeting your acceptance criteria by meeting quality standards. This ensures that semi-automated systems adhere to data integrity.
Computer System Validation Assurance
We specialize in computer system validation, an intricate process ensuring that computerized systems perform accurately and consistently meet regulatory standards. This service is crucial for maintaining the integrity and compliance of your technological operations.
Cleaning Validation
Our cleaning validation services are essential in the pharmaceutical and manufacturing sectors, confirming the effectiveness of cleaning protocols in eliminating residues. This ensures product safety and quality, maintaining stringent standards of cleanliness and compliance.
Regulated Agile SDLC
Our expertise encompasses evaluating your product management tools (e.g., JIRA), integrating with CI/CD tools (e.g., GitHub), and developing a cohesive agile methodology. This approach ensures continuous validation of your system with every sprint cycle, enhancing efficiency and reliability in your digital healthcare solutions.
Expert Validation For IaaS, PaaS, & SaaS Systems
Our comprehensive services include thorough feasibility analysis, seamless implementation, and customized configuration support across Software as a Service (SaaS), Platform as a Service (PaaS), and Infrastructure as a Service (IaaS) models. Trust us to empower your cloud computing strategy.