GMP LIMS

Sapio GMP LIMS offers unmatched flexibility for GMP processes, catering to highly regulated industries such as pharmaceuticals, food and beverage, and chemicals. It is designed to comply with evolving regulations while maintaining meticulous documentation. The system is configurable with no or low code, supporting GMP processes efficiently.

The platform is compliant with 21 CFR Part 11 and EU Annex 11, empowering labs to maximize quality and maintain compliance without disrupting operations. Key capabilities include Quality Control (QC), Environmental Monitoring (EM), and Stability Management, all integrated into a single, science-aware solution.

Maintain Compliance Across Industries

Sapio is designed for compliance in industries like pharmaceuticals, clinical research, food and beverage, environmental testing, petrochemicals, and cosmetics. It provides a GMP-compliant suite of solutions that enable labs to maintain accurate audit trails, generate detailed reports, and meet regulatory standards effortlessly.

Enhance Efficiency and Accuracy

With full traceability, workflow step flagging, and data standardization, Sapio simplifies QC and compliance. It helps track requirements and compile necessary information for regulatory authorities efficiently.

Data Integrity and Security

Sapio ensures data integrity and security with robust audit trails and electronic signatures in an access-controlled platform. It consolidates data in one solution, maintaining confidence in its safety and security.

Adaptability and Scalability

The platform is fully configurable, adapting to the needs of both small labs and large manufacturers. It ensures compliance and allows for quick adaptation to changing regulatory requirements.

Key Features

• Quality Control LIMS: Streamlines material and product management with configurable dashboards, automates sampling plans, and integrates analytical testing.
• Environmental Monitoring: Facilitates routine and non-routine testing with AI-powered plan generation, comprehensive traceability, and advanced data visualization.
• Stability Monitoring: Streamlines stability studies setup and execution, supports detailed study parameters, and integrates with ELN for seamless access to data.

Sapio's platform is specifically designed to enhance productivity and compliance by integrating seamlessly into existing workflows, avoiding inefficiencies and risks associated with multiple disparate systems.