Unlock Pharma Lab Excellence: Expert LIMS Solutions for Compliance & Efficiency

GenBioCa specializes in delivering comprehensive LIMS consulting, tailored for the unique demands of the Pharmaceutical Industry. Founded by technocrats, we empower your lab with insightful, data-driven solutions.

The GenBioCa Advantage: Pharma-Centric LIMS Expertise

We go beyond generic LIMS, offering deep industry understanding of GxP, 21 CFR Part 11, and pharma-specific workflows. Our expert-led implementation and integration ensure your LIMS is a strategic asset for both efficiency and regulatory adherence.

Our Pharma-Focused LIMS Services:

• Pharma-Specific Needs Assessment: In-depth analysis considering regulatory mandates and workflow optimization.
• GxP-Focused LIMS Selection & Implementation: Guiding selection and ensuring compliance, data integrity, and audit trails.
• Regulatory-Minded System Integration: Seamlessly connecting LIMS with lab instruments and enterprise systems for compliant data flow.
• Pharma Workflow Customization & Configuration: Tailoring the LIMS to your specific lab processes (sample management, testing, batch release, stability).
• Validated Data Migration: Ensuring smooth, compliant data transfer with maintained integrity.
• Pharma Best Practices Training & Support: Comprehensive user training aligned with regulatory guidelines.
• Ongoing Compliance & Optimization: LIMS upgrades and maintenance to meet evolving regulations.

Product Expertise: We offer 100% services across all major LIMS platforms, including LabWare, LabVantage, SampleManager, and STARLIMS.

Functional Spectrum includes:

• LIMS Platforms: STARLIMS, LabVantage, LabWare LIMS, SampleManager, SQL*LIMS, Watson, Oasis LIMS
• ELN Solutions: Dassault Velquest’s SmartLab GMP ELN, SYMYX, IDBS eWorkbook Suite 7.1, CambridgeSoft ELN, Waters ELN
• CDS Platforms: Empower, Chromeleon, EZChrom, ChemStation
• SDMS Solutions: NuGenesis, OpenLAB
• Instrument Interfacing: LIMSLink, Logilab Pro, Labstation

Benefits for Your Pharma Lab:

• Enhanced Regulatory Compliance through our deep pharma expertise.
• Streamlined Lab Workflows for increased efficiency.
• Improved Data Integrity & Traceability for reliable, auditable data.
• Reduced Risk of Errors & Non-Compliance with our tailored approach.
• Faster Audit Readiness with a well-implemented, pharma-focused LIMS.
• Maximized ROI on Your LIMS Investment as a strategic asset

Client Success Story (Oil & Gas – Demonstrating Core Expertise):

A major Oil and Gas company faced LIMS implementation and support issues. GenBioCa streamlined processes, workflows, UX, and functionality, implemented a ticketing system with a known error database, provided DIY training, and coordinated with the OEM. This resulted in a 30% reduction in ticket count over two quarters and zero CAPA/RCA on high-impact processes.

Ready to Optimize Your Pharma Lab?

Visit www.genbioca.com or contact sales@Genbioca.com to explore our Pharma-focused LIMS Solutions.

For more information, please refer LIMS Brochure

GenBioCa Lab Informatics Services – FAQs

1. What is Lab Informatics?

Lab informatics involves the use of software systems like LIMS (Laboratory Information Management Systems), ELN (Electronic Laboratory Notebooks), CDS (Chromatography Data Systems), and SDMS (Scientific Data Management Systems) to streamline laboratory workflows, manage data, and ensure regulatory compliance.

2. Why is Lab Informatics important?

Effective lab informatics improves data accuracy, workflow automation, regulatory compliance, and operational efficiency, allowing laboratories to make better data-driven decisions.

3. What LIMS platforms does GenBioCa support?

GenBioCa provides product-agnostic LIMS consulting services for:

• LabWare
• LabVantage
• SampleManager
• STARLIMS
• SQL*LIMS
• Watson LIMS
• Oasis LIMS

4. What services does GenBioCa offer in Lab Informatics?

We offer end-to-end Lab Informatics solutions, including:

• LIMS Implementation & Integration
• System Configuration & Customization
• Business Process Analysis & Strategic Roadmap Development
• Data Migration & Governance
• Validation & Regulatory Compliance
• Ongoing Application Support

5. Does GenBioCa provide ELN (Electronic Laboratory Notebook) solutions?

Yes, we support multiple ELN platforms, including:

• Dassault Velquest’s SmartLab GMP ELN
• SYMYX ELN
• IDBS eWorkbook Suite 7.1
• CambridgeSoft ELN
• Waters ELN

6. How does GenBioCa ensure compliance with regulatory standards?

We ensure adherence to global regulatory frameworks, such as:

• FDA 21 CFR Part 11
• GAMP 5
• ISO 17025
• GLP/GMP Guidelines
• MHRA, EMA, and WHO Compliance

7. What instrument interfacing solutions does GenBioCa provide?

We integrate laboratory instruments with LIMS using:

• LIMSLink
• Logilab Pro
• Labstation

8. Can GenBioCa help with chromatography data systems (CDS)?

Yes, we support CDS platforms, including:

• Empower
• Chromeleon
• EZChrom
• ChemStation

9. What SDMS (Scientific Data Management Systems) solutions does GenBioCa offer?

We support leading SDMS platforms such as:

• NuGenesis
• OpenLAB

10. What additional lab informatics services does GenBioCa provide?

Beyond core LIMS and ELN solutions, we offer:

• Enterprise Architecture & Solution Selection
• Vendor Coordination & Reference Checks
• Risk Analysis & Validation Planning
• Implementation Assessments & Application Roadmaps
• Scheduled & On-Demand Support

11. How does GenBioCa approach data migration and governance?

Our team ensures secure and seamless data migration while maintaining data integrity, compliance, and accessibility, following best practices in data governance and validation.

12. What makes GenBioCa different from other lab informatics providers?

• 100% product-agnostic approach with expertise across multiple platforms.
• Global presence with a nearshore center in Thane, Maharashtra, India.
• Deep industry experience in pharma, biotech, and healthcare.
• End-to-end services, from strategy to implementation and post-go-live support.

13. Does GenBioCa provide cloud-based LIMS solutions?

Yes, we assist with cloud-based LIMS implementation, integration, and validation, ensuring security, scalability, and regulatory compliance.

14. How can I get started with GenBioCa’s Lab Informatics services?

You can contact us through our website, email, or phone to schedule a consultation. Our team will assess your laboratory needs and develop a tailored informatics solution.