Quality & Compliance Management
Our business revolves around bringing the best technology available to organizations that are heavily regulated and that by necessity rely on relatively intricate processes to meet their goals. We enjoy streamlining the complex, and we know which technology components to bring together into your total solution.
Case Study: PGxHealth (PDF 185 KB) – How a leading biopharmaceutical company shifted to a more compliant environment within its clinical laboratory.
GxP Partners brings you solutions from technology leaders for:
Quality Management – Enterprise software for managing quality, compliance, environmental, and health & safety processes. Solutions provide flexible web-based integrated modules that enable you to easily manage processes and communication for: document control, corrective and preventive action, complaint handling and material returns, incident and deviation reporting, audits and surveys, change management, employee training, calibration and maintenance, and project management.
Learning Management – Controlling training content, creation and delivery of assessments, and management of employee training records based on requlatory requirements in a 21 CFR Part 11 compliant environment. Enterprise-wide solutions provide flexibility in the definition of job specific training requirements, the development and delivery of SCORM-compliant training content to each employee, and the delivery of random questions in an interactive environment to gauge the knowledge retained.
Compliance Management - Managing regulatory submissions, structured product labeling, product information, and clincial trial disclosure using state-of-the-art web-based applications that are compliant with government regulations. These solutions automate the paper-based processes and are pre-configured to comply with different global standards and regulations mandated for labeling, disclosure, and product submissions.
Compliance and Quality (PDF, 160 KB)