Accelerate Biotech Innovation with Custom Software

From LIMS to clinical trial management, Bookuvai builds GxP-compliant biotech software that accelerates research, regulatory submissions, and time to market.

Industry: Biotech

Pain Points

  • GxP Validation Requirements: Biotech software must meet FDA 21 CFR Part 11 and EU Annex 11 requirements for electronic records and signatures. Validation protocols (IQ/OQ/PQ) add months to deployment timelines.
  • Complex Data Pipelines: Genomics, proteomics, and high-throughput screening generate terabytes of data that must be processed, analyzed, and stored with full traceability and audit trails.
  • Siloed Research Data: Research teams often use disconnected spreadsheets, ELNs, and LIMS that make cross-experiment analysis, data sharing, and regulatory submission assembly painfully manual.

Solutions

  • Laboratory Information Management (LIMS): Custom LIMS platforms that track samples, experiments, and results with chain of custody, instrument integration, and regulatory-compliant audit trails.
    • Sample chain of custody tracking
    • Instrument data auto-capture
    • SOP-driven workflow enforcement
    • 21 CFR Part 11 electronic signatures
  • Clinical Trial Data Platforms: EDC-adjacent platforms for capturing, cleaning, and analyzing clinical trial data with protocol deviation tracking and regulatory submission packaging.
    • Electronic data capture forms
    • Protocol deviation management
    • Data query and cleaning workflows
  • Bioinformatics Pipelines: Scalable data processing pipelines for genomic sequencing, protein analysis, and compound screening with visualization dashboards for researchers.
    • Nextflow/Snakemake pipeline orchestration
    • Sequence alignment and variant calling
    • Interactive result visualization
    • Cloud-based elastic compute scaling

Use Cases

  • Custom LIMS for Cell Therapy Lab — A LIMS tracking cell therapy manufacturing from donor sample receipt through processing, testing, release, and shipping with full GMP compliance. (250-350, $500-$700, 12-16 weeks)
  • Clinical Trial Dashboard — A dashboard for clinical operations teams to monitor enrollment progress, protocol deviations, adverse events, and site performance across trial sites. (180-260, $360-$520, 10-12 weeks)
  • Genomic Data Analysis Portal — A web portal for researchers to upload sequencing data, run analysis pipelines, visualize results, and collaborate on findings with audit-logged access control. (160-240, $320-$480, 8-12 weeks)

Compliance Notes

  • FDA 21 CFR Part 11 electronic records and signatures
  • GxP Good Practice guidelines (GLP, GCP, GMP)
  • EU Annex 11 computerized systems validation

Frequently Asked Questions

Can you build 21 CFR Part 11 compliant software?
Yes. We implement electronic signatures, audit trails, access controls, and data integrity measures that satisfy Part 11 requirements. We also generate IQ/OQ/PQ validation documentation.
Do you handle genomic data at scale?
We build bioinformatics pipelines on AWS Batch or Google Life Sciences that process terabytes of sequencing data. We use Nextflow for pipeline orchestration and S3/GCS for data lake storage.
Can you integrate with our existing ELN?
We integrate with Benchling, LabArchives, and other ELN platforms via their APIs to connect electronic notebook data with LIMS, analytics pipelines, and regulatory submission workflows.
How do you handle validation for regulated biotech software?
We follow GAMP 5 software categorization and produce validation protocols (IQ, OQ, PQ), traceability matrices, and risk assessments as part of the delivery. We work with your QA team to execute validation.