Pharma and Biopharma Lab Data Integration

Name: Lab Data Integration in Pharma & Biopharma Laboratories
Brand: Splashlake

The pharma and biopharma industry demands seamless laboratory integration to maintain data integrity, ensure regulatory compliance, and accelerate drug discovery and development to deliver treatments to patients faster. Splashlake delivers vendor-neutral instrument connectivity that transforms how pharmaceutical organizations manage their scientific data across the entire lifecycle – from early research through clinical trials to manufacturing quality control.

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What Makes Pharmaceutical Lab Integration So Critical?

Pharma and biopharma laboratories generate vast amounts of complex data from diverse instruments and systems, including flow cytometry, next-generation sequencing (NGS), Western blot analysis, and high-resolution microscopy. Without proper integration, scientists waste valuable time manually transferring large files and transcribing results, increasing the risk of errors that could compromise research outcomes or regulatory submissions. Modern pharmaceutical operations require bi-directional communication between instruments and data management systems to maintain the pace of innovation while meeting stringent compliance requirements. The challenge intensifies when organizations operate with siloed data across legacy systems and multiple LIMS and ELN platforms. Scientists spend countless hours searching for historical data on previously investigated drug candidates – information that could eliminate duplicate testing and expedite costly R&D processes. Splashlake’s productized integration approach eliminates these challenges through convention over configuration methodology. This means pharma and biopharma organizations can connect their entire instrument ecosystem through a single interface, from analytical balances to complex chromatography systems, without custom coding, scripting, or orchestration workflows. The result is a scalable, reliable solution that manages even the largest data files while growing with your laboratory’s evolving needs.

How Does Splashlake Support Pharmaceutical Compliance Requirements?

Regulatory compliance in pharmaceutical environments requires complete data traceability and integrity throughout the drug research, development and production lifecycle. Splashlake captures and collates all raw data and metadata in future-proofed, non-proprietary formats that remain accessible without the original instrument software, ensuring organizations can demonstrate compliance with GLP/GMP requirements and other regulatory frameworks.

Key Compliance Features

Splashlake provides comprehensive compliance capabilities that strengthen your laboratory’s data integrity framework across all regulatory requirements:

Complete Audit Trails – Every data update or edit is logged within Splashlake, creating an unalterable record of who, what, why, and when for your entire data story.
Long-term GLP/GMP Archival – Enables organizations to demonstrate regulatory compliance with automated archival of study data into non-proprietary human-readable format, and archivists managing deposit, retrieval, and reading room processes for audit situations.
Digital Signatures – Through partnership with Thales, digital signatures prove analysts performed tests according to SOPs, while organizations encrypt their data and retain complete control of their encryption keys with Bring Your Own Key technology for cloud sovereignty.
Data Integrity Assurance – Splashlake packages data sets into a non-proprietary format, delivering holistic data and metadata across all techniques and modalities. Metadata tagging enables granular data governance and permissions control, ensuring only authorized users can view or access specific data sets.

Which Laboratory Systems Can Splashlake Connect?

Pharmaceutical laboratories rely on diverse systems that must work together seamlessly to support everything from drug discovery to batch release processes. Splashlake provides proven integrations with leading pharmaceutical software platforms while maintaining vendor neutrality across your instrument fleet.

LIMS Integration Capabilities

Splashlake delivers bi-directional integration between your LIMS and all laboratory instruments and equipment through a single interface, securing data integrity and compliance:

Improve Quality – Send worklists directly to instruments and receive results back into LIMS automatically. Splashlake’s standardized approach connects all instruments in your ecosystem, reducing integration time from months to days while ensuring confidence in solid, robust integrations that eliminate manual transcription errors.
Connect Your Ecosystem – Vendor-agnostic, bi-directional integration enables faster connectivity to more instruments, delivering greater return on investment while maintaining FAIR data principles and freeing scientists for more value-add tasks.

CDS Integration Excellence

For pharmaceutical companies using CDS, Splashlake provides native CDS integration that enhances analytical workflows:

Complete Workflow Traceability – Standardized export of raw data, metadata, methods, results, and reports is delivered in an open XML format. This comprehensive data capture supports regulatory compliance and strengthens data integrity throughout your analytical workflows.
Rich Contextual Data – Store all data related to every run, creating an unrivaled knowledge base for identifying issues and trends, enabling root cause analysis, determining batch failures in manufacturing, and preparing for AI/ML applications in drug discovery and development.

What Types of Pharmaceutical Data Can Splashlake Manage?

Unlike solutions limited to file management, Splashlake handles six distinct data types critical to pharmaceutical operations, surpassing other SDMS solutions that struggle with the movement and management of large pharmaceutical files. This versatility ensures comprehensive data capture across your entire laboratory ecosystem.

The platform manages files from any instrument including large flow cytometry and NGS datasets, simple instrument data from balances and pH meters, continuous time series data from bioreactors and environmental monitoring systems, automatically or manually extracted metadata for searchability, relational data linking experiments and samples across pre-clinical and clinical studies, analytical data throughout QA, and chemical structures essential for drug discovery workflows.

This comprehensive approach enables scientists to connect all data related to particular drug candidates across studies, simplifying regulatory approval preparations.

How Does Splashlake Enable Pharmaceutical Innovation?

Splashlake’s unified data viewer and advanced analytical capabilities empower pharmaceutical scientists to accelerate discovery and streamline operations. Through data cataloging capabilities, scientists can search and access data across all sources without needing original instrument software, viewing historical data from years of research to determine if work has been done on particular compounds before.

The platform provides Python notebooks for an interactive environment that allows intuitive and flexible workflows for exploring data, prototyping code, and sharing results. Users can overlay multiple datasets for comparative analysis, customize visual representations to support specific research needs, and apply processing tools to clean, analyze, and interpret data efficiently.

For pharmaceutical manufacturing, Splashlake expedites the critical batch release process by integrating LIMS, Quality Management Systems (QMS), and Manufacturing Execution Systems (MES). This integration enables scientists to quickly collate information required for batch release decisions, reducing the time high-value products sit waiting for approval and getting medications to patients faster while managing finite shelf lives.

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Transform your pharmaceutical laboratory operations with Splashlake’s proven integration solutions. Contact us today to discover how our productized approach can accelerate your research, ensure compliance, and unlock the full potential of your scientific data.