Sapio QC LIMS

Unmatched flexibility for your GMP processes

quality control qc lims manufacturing

Elevate quality with Sapio’s configurable QC LIMS.

Maintaining stringent quality control is essential for compliance and operational efficiency in highly regulated manufacturing industries such as pharmaceuticals, food and beverage, and chemicals. A robust Quality Control LIMS (Laboratory Information Management System) is crucial for adapting to evolving regulatory requirements while ensuring meticulous documentation.

Sapio’s suite of solutions, compliant with 21 CFR Part 11 and EU Annex 11, empowers laboratories and regulated organizations to enhance their quality control processes efficiently. With powerful capabilities tailored for Quality Control, including Environmental Monitoring (EM) programs and Stability Management, Sapio enables labs to uphold the highest quality standards without hindering scientists’ workflows. This comprehensive, science-aware™ lab informatics platform features built-in tools and no-code configurability, seamlessly supporting the complex and dynamic needs of laboratory projects.

Sapio’s QC LIMS is 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.

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 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.

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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.

Sapio Quality Control (QC) LIMS
All in a single, science-aware™ solution

Lab quality control

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 the 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

GMP lab solution resources

Blog Post

Initiating a Chain of Custody Program in the Laboratory

Read More
Read Post – Initiating a Chain of Custody Program in the Laboratory

Brochure

GMP LIMS Product Flyer

Read More
Download Brochure – GMP LIMS Product Flyer

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.