Sapio GMP LIMS

Unmatched flexibility for your GMP processes

hd gmp solutions

Elevate quality with Sapio’s configurable no/low-code GMP LIMS.

Highly regulated manufacturing industries like pharmaceuticals, food and beverage, and chemicals demand the ability to comply with regulations and seamlessly and rapidly adapt as requirements evolve. Maintaining compliance requires a LIMS system that can be easily configured with no/low code to support your GMP processes and meticulous documentation requirements.

Sapio’s 21 CFR Part 11 and EU Annex 11-compliant suite of solutions empower labs and highly regulated organizations to maximize quality and maintain compliance efficiently while maintaining their rapid speed of operations. With powerful GMP capabilities such as Quality Control (QC), Environmental Monitoring (EM) programs, and Stability Management, Sapio empowers labs to uphold the highest standards for quality without disrupting scientists’ progress. This is part of a single, science-aware™ lab informatics platform—with built-in tools and no-code configurability to support scientists’ complex and ever-evolving project requirements.   

Sapio’s GMP solutions are built for quality and compliance.

icon maintain compliance

Maintain compliance in your industry

Sapio is made for compliance across industries spanning pharmaceuticals, clinical research, food and beverage, environmental testing, petrochemicals, cosmetics, and more. With a state-of-the-art, GMP-compliant suite of solutions, Sapio enables labs to maintain accurate audit trails, generate detailed reports, and meet regulatory standards with ease.

icon elevate efficiency

Elevate efficiency and accuracy

By supporting full traceability, flagging workflow steps or deviations for review, and standardizing data, Sapio makes QC and compliance simple. Keep track of requirements and compile the information you need for regulatory authorities without significant time, effort, or error.

icon safeguard sensitive data

Safeguard your sensitive data

Sapio supports the highest levels of Data Integrity and Security with robust audit trails and electronic signatures, in an access controlled and permission-based platform. Bring your data together in one solution and maintain confidence in its safety and security within our fully compliant platform.

icon adapt and scale

Adapt and scale as requirements evolve

As a fully configurable platform, Sapio works the way scientists do. Whether you are a small lab or a large manufacturer, Sapio seamlessly adapts to your requirements with no-code configurability and ensures compliance at every step. Meet new requirements as your processes  grow and quickly adapt to changing regulatory requirements.

Discover how Sapio supports compliance in regulated environments.

Quality Control (QC), Environmental Management (EM), and Stability monitoring. All in a single, science-aware™ solution.   

Sapio brings QC, EM, and stability management together in a unified informatics platform built for scientists.

quality control lab information management system

Quality Control Laboratory Information Management System (QC LIMS)

Our new QC LIMS module streamlines material and product management with configurable dashboards, drug product registration, and batch creation. QC LIMS automates sampling plans and testing workflows, ensuring efficient batch and sample management. The module integrates analytical testing with automatic pass/fail determinations, capturing detailed data for each sample. QC LIMS allows for trending of sample data within and across batches. When a batch is complete and ready for release,  the QC LIMS can generate a Certificate of Analysis or Certificate of Release with electronic signature support, which ensures comprehensive documentation by embedding COA/CORs process within the seamless workflow.

Sapio QC LIMS Key Features:

Material and Product Management:

  • Configurable product dashboards
  • Unique drug product registration
  • Drug product batch management

Batch Creation and Sample Management:

  • New batch creation with meta data
  • Automatic sampling plan generation
  • Sample request and rejection handling
  • Comprehensive sample storage management

Analytical Testing and Results:

  • Manual and automated data recording
  • Pre-configured assays and acceptance criteria
  • Automatic pass/fail sample determination
  • Multiple parameters capture for samples

Certificate Generation and Approval:

  • Automatic COA and Certificate of Release
  • Electronic signature support
  • COA embedding in Certificate of Release
environmental monitoring

Environmental Monitoring

Sapio’s Environmental Monitoring Program module facilitates both routine and non-routine testing plan setup with AI-powered generation of plans from site images and customizable templates. The module streamlines EM scheduling, result recording, integration with equipment, and automatic evaluation against predefined criteria, ensuring comprehensive traceability and trending across sampling sites and time points. Data visualization and analysis features include interactive trend charts, heat maps, and advanced analytics for identifying trends and potential issues, providing a robust solution for environmental monitoring.

Sapio Equipment and Storage Management Key Features:

Site, Equipment, and Storage Management:

  • Manufacturing sites and equipment tracking
  • Equipment maintenance and metadata recording
  • Equipment integration for automated result capture
  • Hierarchical storage unit organization

EM Test Plan Setup:

  • Environmental monitoring routine templates
  • AI-powered test plan generation
  • Customizable non-routine test plan creation

Measurement and Result Recording:

  • Measurement scheduling and tracking
  • Recording of results including comment fields
  • Automatic result evaluation and alerts
  • Traceability of measurements

Data Visualization and Analysis:

  • Interactive data visualization tools
  • Drill-down investigation capabilities
  • Advanced data analytics and reporting
stability management

Stability Management

Sapio’s Stability Testing Module streamlines the setup and execution of stability studies. Sapio allows the initiation of Stability studies, defines study types, storage conditions, durations, and tracks sample assignments. The module supports detailed study parameters and time point setup, automatically creating and assigning test plans. It schedules and records sample test results, automatically evaluating them against predefined criteria for comprehensive traceability. Reporting features include configurable summary reports, trend analysis, degradation pattern identification, and shelf-life projections. Integration with the ELN ensures seamless access to study protocols, reports, and experimental data.

Stability Testing Module Key Features:

Study Setup and Material Assignment

  • Initiation from drug product batches
  • Definition of study types and conditions
  • Sample assignment and tracking

Study Parameter and Time Point Definition:

  • Study parameter setup
  • Time point and interval definition
  • Automatic testing request creation

Sample Testing and Result Recording:

  • Scheduled sample testing
  • Recording of results and comments
  • Automatic result evaluation
  • Comprehensive result traceability

Reporting and Trend Analysis:

  • Configurable stability summary reports
  • Trend and degradation pattern identification
  • Comparative stability profile analysis
  • ELN integration for seamless access

GMP-compliant lab feature summary

Sapio delivers built-in tools to handle a variety of scientific workflows while enabling organizations to comply with ease. Here are some of the features Sapio delivers to support  GMP compliance.

  • Material and Product Management
  • Batch Creation and Sample Management
  • Analytical Testing and Results
  • Certificate Generation and Approval
  • Site, Equipment, and Storage Management
  • Routine and Testing Plan Setup
  • Measurement and Result Recording
  • Data Visualizations
  • Study Setup and Material Assignment
  • Study Parameter and Time Point Definition
  • Sample Testing and Result Recording
  • Reporting

GMP lab solution resources

Blog Post

Ensuring GMP Compliance: Expert Insights with Robin Stolzberg, Quality Assurance Expert at Sapio Sciences

Read More
Read Post – Ensuring GMP Compliance: Expert Insights with Robin Stolzberg, Quality Assurance Expert at Sapio Sciences

Blog Post

Best Practices for Implementing LIMS in GXP Environments

Read More
Read Post – Best Practices for Implementing LIMS in GXP Environments

Guide

The Ultimate Guide to GXP Compliance: Best Practices for Labs, Clinics, and Manufacturers

Read More
Download Guide – The Ultimate Guide to GXP Compliance: Best Practices for Labs, Clinics, and Manufacturers

Do you have questions about our GMP solutions?

Allow us to answer them.

What industries can benefit from Sapio’s GMP-compliant solutions?

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.  

How does Sapio ensure data integrity and security?

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.  

Can Sapio’s platform adapt to the changing needs of my lab?

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.  

What features does Sapio offer for quality control and compliance?

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.

How does Sapio support environmental management in labs?

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.  

How does Sapio support regulations across regions?

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.

Let us show you how Sapio can support your organization’s quality and compliance requirements.

Fill out the form to request your demo.