Sapio Sciences adds electronic batch record functionality to GMP LIMS platform
Laboratory information management system (LIMS) provider Sapio Sciences has enhanced its GMP LIMS solution with electronic batch record (EBR) functionality, offering expanded capabilities for manufacturing laboratories requiring GMP, 21 CFR 11, and EU Annex 11 compliance.
The integration of EBR functionality provides comprehensive batch-level quality control and traceability throughout the manufacturing process. This development follows the company’s June 2024 launch of their GMP LIMS platform, which already incorporates quality control LIMS, environmental monitoring, and stability testing capabilities.
The system’s architecture employs a template-based approach that enables laboratory personnel to configure batch records without programming expertise. This configuration flexibility extends to workflow customisation, supporting multiple user roles and electronic signature implementation for review and approval processes.
Notably, the platform maintains an immutable audit trail for manufacturing process steps, whilst automating control procedures from raw material management through to final quality control. The system encompasses barcode scanning integration, in-process control monitoring, and real-time reporting functionality.
Kevin Cramer, founder and CEO of Sapio Sciences, emphasised the platform’s role in streamlining compliance procedures, saying: “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.”
The enhanced platform maintains compatibility with existing regulatory frameworks, including 21 CFR Part 11 and EU Annex-11 compliance requirements. Core functionalities encompass configurable dashboards for material and product management, AI-assisted environmental monitoring plan generation, and comprehensive stability study management capabilities.
This development represents a significant advancement in laboratory informatics, particularly for facilities in biotechnology, pharmaceuticals, clinical research and diagnostics, food and beverage, chemicals, and environmental testing sectors requiring stringent quality control measures and regulatory compliance.
The platform’s emphasis on no-code configuration aims to facilitate rapid implementation of compliance requirements whilst maintaining system flexibility for diverse laboratory environments.
For additional information: www.sapiosciences.com
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