Sapio Environmental Monitoring
Unmatched flexibility for your GMP processes
Elevate quality with Sapio’s configurable no Environmental Monitoring.
In highly regulated environments such as pharmaceuticals, food and beverage, and chemicals, effective environmental monitoring is crucial to maintaining compliance and ensuring product integrity. Professionals responsible for environmental monitoring and stability studies face the challenge of meeting stringent regulations while managing complex data and documentation requirements.
Sapio’s suite of solutions is designed to meet these needs head-on, offering a comprehensive, 21 CFR Part 11 and EU Annex 11-compliant platform that streamlines environmental monitoring, stability management, and quality control processes. With user-friendly, low-code configurability, our science-aware™ lab informatics platform empowers labs to efficiently uphold the highest quality standards without hindering scientists’ progress. By integrating powerful environmental monitoring programs, Sapio enables organizations to adapt seamlessly to evolving regulatory demands while ensuring meticulous documentation and compliance in their operations.
Sapio Environmental Monitoring is built for quality and 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 easily meet regulatory standards.
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.
Safeguard your sensitive data
Sapio supports the highest Data Integrity and Security levels 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.
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.
Environmental Management (EM) – a single, science-aware™ solution.
Environmental Monitoring
Sapio’s Environmental Monitoring Program module facilitates 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
GMP lab solution resources
Whitepaper
The High Price of Holding on to Outdated LIMS Systems
Brochure
GMP LIMS Product Flyer
Blog Post
Ensuring GMP Compliance: Expert Insights with Robin Stolzberg, Quality Assurance Expert at Sapio Sciences
Do you have questions about our GMP solutions?
Allow us to answer them.
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.
Let us show you how Sapio can support your organization’s quality and compliance requirements.
Fill out the form to request your demo.