Sapio GMP LIMS

Sapio’s GMP-compliant solutions cater to a wide range of industries, including pharmaceuticals, clinical research, food and beverage, environmental testing, petrochemicals, cosmetics, and more. These sectors are often subject to stringent regulations that require meticulous documentation, consistent quality control, and robust data management. Scientists and lab managers in these industries face significant challenges in maintaining compliance while ensuring operational efficiency.
  
The Sapio informatics platform is specifically designed to address these challenges by providing a unified, configurable solution that integrates seamlessly into existing workflows. This helps labs avoid the inefficiencies and risks of using multiple disparate systems, ultimately enhancing productivity and compliance.  

Scientists often struggle to maintain accurate, tamper-proof records while ensuring that data is easily accessible and secure. The Sapio informatics platform provides robust audit trails that record every action taken within the system, ensuring complete traceability. At the same time, Sapio maintains powerful, context-rich searchability for the scientific user.  

Support for electronic signatures and an access-controlled platform further enhances security by ensuring that only authorized personnel can access and modify sensitive data. By consolidating all data within Sapio’s fully compliant informatics platform, labs can eliminate the risks associated with fragmented data storage, such as data breaches and loss of data integrity, thereby maintaining the highest standards of safety and security.  

Yes, Sapio’s platform is fully configurable and designed to adapt to the evolving needs of your lab. Whether you are a small lab or a large manufacturer, the flexibility of our no-code configurability ensures that you can quickly and easily adjust workflows, data management practices, and compliance protocols as requirements change.   
This adaptability is crucial for labs that face dynamic regulatory landscapes and growing operational demands throughout the product lifecycle. Scientists often need to scale their operations or adjust their processes to accommodate new types of research or regulatory changes. Sapio’s platform supports this by allowing for seamless modifications without extensive IT intervention, ensuring that your lab remains compliant and efficient as it grows and evolves.  

Sapio offers comprehensive features to support Quality Control and Compliance in highly regulated sectors. These include robust audit trails that ensure every action is traceable, electronic signatures that provide secure and verifiable approval processes, and an access-controlled platform. Automated alerts and notifications help labs avoid potential compliance issues by flagging deviations and essential updates in real-time.   
Built-in regulatory reporting simplifies generating the necessary documentation for audits and inspections. Stability reagent management, study management and instrument integration further streamline lab operations, ensuring that all data and processes are consistent and compliant with regulatory standards.

Sapio supports environmental management with a suite of tools designed to meet the highest standards for safety and cleanliness. Scientists often need to monitor various environmental parameters, manage samples, and ensure compliance with strict regulatory standards. Sapio’s informatics platform provides a built-in environmental monitoring module, which allows integrations with EM software’s to continuously track conditions such as temperature, humidity, and other critical factors. Automated alerts notify lab personnel of excursions from set parameters, allowing a prompt corrective action. Detailed reporting capabilities ensure that all environmental data is readily available for compliance verification/trending. By providing these comprehensive management tools, Sapio helps labs maintain a safe and compliant environment while reducing the administrative burden on scientists.  

Sapio’s GMP-compliant solutions are designed to meet diverse regulatory requirements across different regions, ensuring your lab can operate seamlessly anywhere. Scientists and lab managers often face the challenge of navigating complex regulatory landscapes that vary by region. Our platform fully complies with major regulatory standards, including 21 CFR Part 11 and EU Annex 11, as well as other global standards. This ensures that labs can maintain compliance without implementing multiple systems or undergoing extensive reconfiguration for different regulatory environments. Key features such as flexible configuration, automated compliance checks, comprehensive audit trails, built-in reporting, support for electronic signatures and access control enable labs to adapt quickly to local regulations, providing peace of mind and operational efficiency.