Sapio Electronic Batch Records
Unmatched flexibility for your GMP processes
Introducing Sapio Electronic Batch Records (EBRs)
Maintaining efficiency and quality while adhering to stringent regulations can be challenging in today’s fast-paced, compliance-driven manufacturing environments. Traditional paper-based batch records are prone to errors, delays, and inefficiencies that can disrupt production and affect quality. A modern solution is needed—one that ensures compliance enhances operational efficiency and provides real-time visibility into production processes.
Sapio EBR offers an innovative approach to Electronic Batch Records, leveraging automation and a user-friendly platform to streamline batch production, track materials and equipment, and ensure compliance with regulatory requirements—all without complex coding.
Key benefits of Sapio EBR
Increased Efficiency and Automation
Sapio EBR simplifies the batch production process by automating critical tasks such as material management, equipment tracking, and in-process control. This results in faster, more accurate data entry, reducing manual work and the potential for human errors.
Compliance and Traceability
Ensure full compliance with industry regulations through Sapio EBR’s comprehensive audit trail, which tracks every action taken during production. The immutable audit log guarantees the traceability of all materials, processes, and personnel, meeting even the most stringent regulatory requirements.
Flexibility and Ease of Use
Sapio EBR offers an intuitive configuration of templates and workflows without requiring any coding expertise. With flexible, multiple-role support (e.g., executor, inspector, etc.) and adaptable workflows, Sapio EBR can be tailored to fit the specific needs of any production process.
Real-Time Monitoring and Reporting
Gain real-time insights into batch production with Sapio EBR’s dynamic dashboards and final reports. Automated notifications upon batch completion and direct integration with QC and environmental monitoring ensure timely oversight and decision-making.
Discover how Sapio supports EBR in regulated environments.
Sapio Electronic Batch Record Feature Summary
Sapio EBR stands out from other solutions by offering a seamless combination of automation, user configurability, and real-time monitoring. Sapio’s ease of creating new EBR templates, robust material and equipment management capabilities, and advanced audit and compliance features are all designed to improve accuracy, efficiency, and traceability.
Key Differentiators:
- No-code Template Configuration: Easily create and modify batch records and templates without programming skills.
- Comprehensive Audit and Compliance Tools: An immutable audit log ensures every manufacturing process step is traceable and reviewable.
- Flexible Workflow Customization: Adjust workflows based on your product, process, or regulatory requirements with support for multiple roles and electronic signatures for review and approval.
- End-to-End Batch Process Automation: Automated control from raw material management to final QC, including barcode scanning, in-process control, and real-time reporting.
Sapio EBR Key Features:
Batch Process Management:
- No-code Template Configuration: Create and modify batch records easily without coding.
- Role-Based Access: Support for multiple roles (e.g. executor, inspector) to ensure checks and balances.
- Process Step Completion: Step-by-step tracking of each part of the manufacturing process with electronic signatures.
Material and Equipment Management:
- Raw Material Tracking: Manage material lots, barcoding, weight tracking, and traceability.
- Equipment Validation: Ensure equipment is properly calibrated and maintained, with integrated maintenance schedules and status tracking.
In-Process and Final QC:
- In-Process Control: Enter and validate parameters during the production process.
- Final Quality Control: Automatically submit completed batches for QC review, capturing results from integrated instruments.
Compliance and Traceability:
- Immutable Audit Log: Track every action, from data entry to final approval, with timestamped electronic signatures.
- Deviation Management: Document and review deviations or corrective actions with traceability.
- Automated Reports and Notifications: Generate final batch reports and send notifications upon batch completion.
GMP lab solution resources
Whitepaper
The High Price of Holding on to Outdated LIMS Systems
Brochure
GMP LIMS Product Flyer
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.
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.
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