Sapio Sciences Adds Electronic Batch Record Functionality to Unified GMP LIMS Solution

October 24, 2024

Sapio Sciences Adds Electronic Batch Record Functionality to Unified GMP LIMS Solution

Sapio Sciences announces new capabilities to flexible, no/low-code LIMS

Baltimore, MD, 25 October 2024 – Sapio Sciences, the science-aware™ lab informatics platform, today announced the addition of new Electronic Batch Record (EBR) functionality to Sapio GMP (Good Manufacturing Practice) LIMS. Designed for laboratories that must comply with GMP, 21 CFR 11, and EU Annex 11 standards, the Sapio GMP LIMS offers unparalleled flexibility to meet compliance standards in biotechnology, pharmaceuticals, clinical research and diagnostics, food and beverage, chemicals, and environmental testing.

Announced in June 2024 and built on Sapio Sciences’ industry-leading lab informatics platform, the Sapio GMP LIMS includes a quality control laboratory information management system (QC LIMS), environmental monitoring programs, and stability monitoring.

The addition of EBR functionality extends Sapio GMP LIMS capabilities to track every aspect of the batch manufacturing process, ensuring batch-level quality control and traceability.

Key capabilities include:

  • No-code template configuration: Easily create and modify batch records and templates without the need for coding or 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: Automated control from raw material management to final QC, including barcode scanning, in-process control, and real-time reporting.

 

Kevin Cramer, Founder and CEO of Sapio Sciences, commented: “The addition of Electronic Batch Records into our GMP LIMS will help manufacturers streamline compliance procedures, reduce errors and automate data collection, improve production efficiency, and enable traceability throughout the pharmaceutical supply chain.” Kevin continued: “The increasing compliance demands on manufacturing laboratories make our GMP LIMS an invaluable tool for labs looking to quickly integrate, configure, and automate their unique compliance requirements. Our innovative approach to Electronic Batch Records leverages automation across our user-friendly platform, streamlining batch production, material and equipment tracking, and regulatory compliance, all without complex coding.”

Sapio GMP LIMS automates and streamlines quality control processes, reduces manual errors, enhances overall accuracy, provides end-to-end traceability and audit trails, and improves overall operating quality. In addition to GMP, the solution is also 21 CFR Part 11 and EU Annex-11 compliant.

Key elements of Sapio GMP LIMS include:

  • Sapio QC LIMS: streamlines material and product management with configurable dashboards, drug product registration, and batch creation.
  • Sapio Environmental Monitoring: facilitates both routine and non-routine testing plan setup with AI-powered generation of plans from site images and customizable templates
  • Sapio Stability Monitoring: streamlines the setup and execution of stability studies, including definition and tracking of study type, storage conditions, durations, and sample assignments.
  • Electronic Batch Records: streamlines batch production, materials and equipment tracking

 

For more information on Sapio GMP LIMS, visit: https://www.sapiosciences.com/solutions/gmp-lims/

For more information on EBR functionality, visit: https://www.sapiosciences.com/solutions/sapio-ebr/

About Sapio Sciences

Sapio Sciences' mission is to improve lives by accelerating discovery, and because science is complex, Sapio makes technology simple. Sapio is a global business offering an all-in-one science-aware™ lab informatics platform combining cloud-based LIMS, ELN, and Jarvis data solutions.

Sapio serves some of the largest global and specialist brands, including biopharma, CRO/CDMOs and clinical diagnostic labs across NGS genomic sequencing, bioanalysis, bioprocessing, chemistry, stability, histopathology, and in vivo studies.

Customers love Sapio's platform because it is robust, scalable, and with no-code configuration, can quickly adapt to meet unique needs.

For more information, visit www.sapiosciences.com and follow us on LinkedIn.