Quality Management System
A Quality Management System provides a proven, structured framework for enhancing product quality and facilitating continuous improvement in quality processes.
Document Management System Development and Training
We specialize in crafting tailored document management systems and delivering thorough training for your staff on efficient document maintenance. Our expertise guarantees that your documentation practices remain organized and audit-ready at all times.
Quality Management Systems for Change, Deviation & CAPA
We excel in QMS development for regulated environments, encompassing change control, deviation, and CAPA management. Our services establish robust procedures and programs for effective management notification, fostering continuous QMS improvement, and elevating both regulatory compliance and operational excellence.
Calibration and Preventive Maintenance (PM) Services
Our team provides comprehensive support in evaluating system usability and establishing optimal calibration/PM schedules. We offer expert guidance on internalizing these services, outlining the requisite qualifications for personnel to execute these tasks proficiently and in accordance with industry standards.
Technical Writing and SOP Development Services
We provide thorough support to enhance your technical documentation by offering meticulous proofreading and constructive feedback. Furthermore, our expertise extends to crafting Standard Operating Procedures (SOPs) for operations, maintenance, and Quality Management Systems (QMS), ensuring clarity, compliance, and operational efficiency.
CLIA-CAP Laboratory Compliance and Support Services
Our team specializes in evaluating laboratory processes, implementing essential controls for CLIA-CAP compliance, and conducting targeted training for your staff to prepare for upcoming inspections. We ensure your lab operations meet stringent regulatory standards, enhancing both quality and readiness.