Software Development for Biotechnology & Biomedicine

LIMS, bioinformatics pipelines and GxP-compliant software solutions for laboratories, pharma companies and biotech start-ups.

Software for science – precise, validated, scalable

Biotechnology companies face the challenge of digitally mapping highly complex lab processes while meeting strict regulatory requirements (GxP, FDA 21 CFR Part 11, EU GMP). BitPointer GmbH develops custom LIMS systems, bioinformatics pipelines and validated software that accelerate your research and production processes.

Laboratory information management systems (LIMS): sample management, workflows, reporting
Bioinformatics pipelines: NGS, proteomics, metabolomics data analysis
GxP-compliant software validation (CSV according to GAMP 5)
Lab instrument integration (SCADA, OPC-UA, serial interfaces)
Electronic lab notebooks (ELN) & document management systems
FDA 21 CFR Part 11: audit trails, electronic signatures

Your advantages with BitPointer

GxP validation from day one

We integrate GxP requirements (GAMP 5, CSV) into the development process – not a follow-on validation project, but validation-ready architecture from the start.

Scalable data analysis

From individual lab experiments to genome-wide studies: our bioinformatics pipelines process large data volumes efficiently with Python, R and cloud-native workflows.

Instrument integration & automation

We connect your lab instruments – from pipetting robots to analysers – via standardised interfaces and reduce manual data entry to a minimum.

FDA 21 CFR Part 11 – experience from the lab

Real project experience in a regulated environment

We have contributed to HMI software for biomedical lab instruments of a globally operating biotechnology and biomedicine company — fully under FDA 21 CFR Part 11 compliance:

  • Implementation of new functionality for lab instruments for cell sorting (HMI)
  • Continuous repositioning of the detection optics on fluctuating microchip positions
  • Optimisation of algorithms for optical detection of the end of cell carrier solutions
  • Integration of multi-monitor support with persistent window management on a Wayland compositor
  • Tech stack: C++17, Qt 5.x, QML, eCos real-time OS, Wayland, Yocto, Docker, Kubernetes, Jenkins

Audit trail & electronic signatures

FDA 21 CFR Part 11 requires tamper-proof audit trails for all operator actions and electronic signatures for critical actions. We implement both in Qt/C++ applications.

Real-time operating systems (eCos)

Lab instrument HMIs often run on real-time operating systems. We have productive experience with eCos RTOS and embedded Linux (Yocto) in regulated lab environments.

Computer vision in lab automation

Optical recognition for cell sorters: algorithms for positioning and state detection under fluctuating conditions — real experience from biomedical projects.

FAQ

Frequently asked questions about biotechnology software

GAMP 5 (Good Automated Manufacturing Practice) is an ISPE framework for validating computerised systems in the pharmaceutical industry. It classifies software into categories (1–5) and defines the corresponding validation effort. For LIMS, ELN and other lab applications, GAMP 5 is the foundation of FDA- and EU-GMP-compliant software validation (CSV – Computer System Validation).

Yes. We analyse your existing LIMS installation, identify extension points and develop modules or integrations that embed seamlessly. For a migration, we help with data export, transformation and validated import into the target system – without data loss and with a complete audit trail.

For bioinformatics pipelines we use Python (BioPython, Pandas, NumPy, Snakemake, Nextflow) and R (Bioconductor). Cloud-native workflows are implemented on AWS Batch, Google Life Sciences or Azure Machine Learning. For performance-critical analyses we can also use C++ or Julia.

Subject and patient data in clinical studies are subject to strict requirements (GDPR, BDSG, GCP). We implement pseudonymisation, role-based access control and encrypted data storage. All systems run on German or EU servers. On request we support you in preparing a Data Protection Impact Assessment (DPIA).

Yes. We have experience integrating instruments via serial interfaces (RS-232/RS-485), OPC-UA, MODBUS and manufacturer-specific SDKs. For common analysers (PCR, HPLC, spectrometers) standardised drivers often exist. For proprietary protocols we develop custom adapter layers.

Ready to start a biotech software project?

Let’s talk about your LIMS, bioinformatics pipeline or GxP validation project – free of charge and without obligation.

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