BioLyte

BioLyte is a bioanalytical Laboratory Information Management System (LIMS) developed by Sarjen Systems, designed specifically for bioanalytical laboratories operating in regulated environments. It automates data review and streamlines laboratory workflows, with the goal of reducing human error, accelerating data validation, and maintaining end-to-end data integrity.

The solution is built for labs that need to meet regulatory requirements including 21 CFR Part 11, GLP, and GxP compliance. It integrates with laboratory instruments to replace manual processes, helping labs reduce turnaround times, lower operational costs, and scale efficiently while meeting audit requirements.

Core Features

• Automated data review: Automates the review of bioanalytical data to reduce manual effort and minimise errors in the review process.
• Instrument integration: Connects directly with lab instruments to capture data without manual intervention.
• Error-free data validation: Applies automated validation checks to ensure accuracy and consistency of results.
• Real-time data access: Provides access to laboratory data in real time, supporting timely decision-making.
• Advanced data security: Incorporates security controls to protect laboratory data and support audit trail requirements.
• Regulatory compliance readiness: Supports compliance with 21 CFR Part 11, GLP, and GxP standards for regulated bioanalytical environments.
• Enhanced productivity: Streamlines workflows to increase throughput and reduce time spent on manual tasks.
• Cost efficiency: Reduces operational costs by automating processes that would otherwise require manual resources.

Compliance and Regulatory Support

• Supports 21 CFR Part 11 requirements for electronic records and signatures.
• Designed to meet GLP (Good Laboratory Practice) and broader GxP compliance standards.
• Helps laboratories prepare for and meet audit requirements.

Broader Platform Context

• BioLyte is part of Sarjen Systems' wider portfolio, which also covers clinical research (early- and late-phase trials), pharmacovigilance, regulatory solutions (eCTD publishing, RIMS, eCSV), quality management, pharmaceutical manufacturing (MES), supply chain, and CRM.
• Sarjen Systems also offers related services including regulatory services, Power BI, SAP, AI and automation, and custom project services.

BioLyte is offered as a compliance-ready, specialised LIMS solution for bioanalytical labs seeking to automate data workflows and meet regulatory standards. Prospective users can request a demo directly through Sarjen Systems.