QC LIMS

Sapio Laboratory QC LIMS offers unmatched flexibility for GMP processes, crucial for maintaining stringent quality control in regulated industries like pharmaceuticals, food and beverage, and chemicals. This robust Laboratory Information Management System (LIMS) adapts to evolving regulatory requirements while ensuring meticulous documentation.

Compliant with 21 CFR Part 11 and EU Annex 11, Sapio's QC LIMS empowers laboratories to enhance quality control processes efficiently. It includes capabilities for Environmental Monitoring (EM) programs and Stability Management, enabling labs to uphold high quality standards without disrupting workflows. The platform is science-aware™, featuring built-in tools and no-code configurability to support complex laboratory projects.

Sapio QC LIMS is designed for compliance across various industries, including pharmaceuticals, clinical research, food and beverage, environmental testing, petrochemicals, and cosmetics. It helps labs maintain accurate audit trails, generate detailed reports, and meet regulatory standards with a GMP-compliant suite of solutions.

Key features include:

• Material and Product Management: Configurable dashboards, unique drug product registration, and batch management.
• Batch Creation and Sample Management: New batch creation with metadata, automatic sampling plan generation, and comprehensive sample storage management.
• Analytical Testing and Results: Manual and automated data recording, pre-configured assays, automatic pass/fail determinations, and multiple parameter capture for samples.
• Certificate Generation and Approval: Automatic Certificate of Analysis (COA) and Certificate of Release with electronic signature support.

Sapio ensures data integrity and security with robust audit trails and electronic signatures in an access-controlled platform. It supports full traceability, flags workflow deviations for review, and standardizes data, simplifying QC and compliance. The platform adapts to changing requirements, making it suitable for both small labs and large manufacturers.

Discover how Sapio supports compliance in regulated environments, offering a unified solution that integrates seamlessly into existing workflows, enhancing productivity and compliance.