Features

phage genome quality control tool

Features to Support
GMP-Compliant Phage Production

For Phages & Plasmids

gmp certificationalcoa+ certificationgdpr certification
FDA 21 CFR Part 11 Compliant Electronic Signatures
Built for GMP Annex 11 Compliance Following GAMP 5

Key Features

BatchQC is the GMP-compatible bioinformatics QA layer for manufacturing phage products. Automated pipelines combine multiple industry-standard tools for contamination screening, genome stability monitoring, and configurable batch pass/fail. Your QA team drives it from a web interface without writing code, and a GMP-compliant audit trail captures every step.

Automated Workflows

Customisable production pipeline
Tiered architecture matched to your workflow

Bioinformatics Pipeline & Data

Customisable production pipeline
Tiered architecture matched to your workflow
Multi-platform NGS analysis
Illumina, Nanopore and PacBio in one validated workflow
Phage-aware genome topology
Linear, circular, T4, T7, lambda — declared on upload
Phage contamination detection
Control genomes debited, not double-counted

Compliance & Records

21 CFR Part 11 signatures
Every artefact signed, timestamped, verifiable offline
Lot disposition with separation of duties
Approve/reject with permanent signature chain
Signed Certificate of Analysis (CoA) document
Self-contained PDF with content hash

Signing & Configuration

Signed mapping presets
Per-technology aligner params, digitally locked on approval
Signed QC gates
21 rule types, tuned per phage, applied identically every batch

Access & Audit

Role-based access control
31 permissions, time-bounded delegation, MFA
Tamper-evident audit trail
GxP-relevant changes, filterable and exportable

BatchQC

Manage Your Entire Genomic QC From One Platform

BatchQC handles the full phage genomic QC workflow on one platform. Sequencing data flows through a validated bioinformatics pipeline against your signed-off QC gates: the disposition is captured with electronic signatures and a Certificate of Analysis emerges with the full genomic QC report attached. Everything happens efficiently inside the platform, so you can focus on releasing your next batch.

User interface showing mapping results for sample labeled WSL1 with status Approved. Workflow is complete. Primary quality metrics display variants detected as 17, mapping efficiency 20.1%, coverage depth 72x, and genome coverage 98.8%. Tabs include Overview (selected), Raw reads, Depth, Variants, Rulesets, Signatures, and Disposition.

Analyse

  • Customise your QC workflow to match your organisation’s production pipeline
  • Run validated bioinformatics pipelines with multi-platform sequencing support
  • Configurable to your specific phage QC needs and phage genome types
  • No code or command line expertise needed
  • Accessible: code-free, intuitive and graphical interface
Signature details panel showing verification passed on 2026-08-17 03:00. Signed by Ville Hoikkala from organisation PrecisionPhage for project_123 as Admin role, signed at 2026-06-26 13:09. Signing target is WSL1 Lot with purpose Lot approval.

Sign off

  • 21 CFR Part 11 compliant signatures for every step
  • Multi-role disposition workflow
  • Role-based access control
  • Organisational policies
  • Configuration change control
A table showing user activity log with columns labeled User, Action, Target, Details, and Timestamp. Entries show user Ville Hoikkala performing actions on June 26, 2026, including updating a Lot (ID 74) labeled Working Seed Lot at 13:09, and creating Signatures (IDs 90, 87, 88, 89) with details about runs and rulesets between 13:07 and 13:08, plus creating Results (ID 50) at 12:48.

Document

  • GxP audit trail
  • Certificate of Analysis export
  • ALCOA+ GMP-ready data integrity
  • Runs and reports in one system
  • Validation evidence package on request

Modern Phage Production Workflow

With Phage Genomic QC, Built For GMP
Ready on day one

Phage-aware QC out of the box

Quality thresholds and mapping presets calibrated for phage genome diversity — not retrofitted from generic genomics.

Speed

Faster batch release

Pre-approved checker pipelines display a verdict the moment analysis completes. Disposition becomes a review, not an analysis.

Simplicity

One platform for your whole team

Analysis, signing, CoA generation and audit trail in one web interface. No scattered scripts or manual report assembly.

Compliance

Inherit the validation, don't redo it

Quality thresholds and mapping presets calibrated for phage genome diversity — not retrofitted from generic genomics.

Infrastructure

EU-hosted on validated infrastructure

Quality thresholds and mapping presets calibrated for phage genome diversity — not retrofitted from generic genomics.

Compatibility

Genome sequencer

Illumina, Nanopore and PacBio in one validated pipeline with platform-aware mapping and variant calling. No forced hardware migration.

Set Your Production Journey Up for Success
– With Us, You Get Both

Software & Expert Support

For Phages & Plasmids

batchqc phage software
With BatchQC, you will not only gain access to GMP-compliant software designed for independent, day-to-day use by your entire team...
batchqc expert support
... you also gain the support of our expert team, a dedicated partner by your side throughout your phage production journey.
People

The Team Behind Phagenomics BatchQC

Phagenomics BatchQC is developed by PrecisionPhage, a company dedicated to furthering groundbreaking research and innovative solutions that drive success in biotechnology. Our commitment to excellence has established us as a trusted partner in the industry.

40+

Years of combined phage research experience

10+

years experience of pioneering phage therapy in Finland

2000+

assembled & annotated phage genomes

150+

peer-reviewed publications

BatchQC Add-Ons

Expert Support at Every Stage of Your Journey 

Starting out

Validation Package

Use our validation package to streamline deploying BatchQC to your workflow. The package includes a comprehensive set of user requirement specifications, risk analysis and mitigations, test results, cybersecurity and infrastructure reports, mappings to relevant standards, and more.

Starting out

Configuration Health Check

There is no one-size-fits-all with phages, which is why BatchQC was built to support the diversity in phage genomes and in QC methods across organisations. Our experts will guide you through customising mapping preset, rulesets and organisational policies to ensure your genomic QC aligns with your actual needs.

During operation

Premium Support & SLA

For clients with strict requirements for maintaining validation documentation in a structured manner. Gives you access to BatchQC's validation environment well in advance before we ship GxP-relevant updates, with updated validation documentation. Premium support includes priority in support requests.

During operation

Single Tenancy

For clients requiring maximal data isolation, we offer single tenancy deployment of BatchQC in dedicated infrastructure. While the our standard multitenancy is built with strict isolation controls, single tenancy servers those with organisational policies requiring single tenancy.

Optimisation

Extended Data Storage

Retention of all central analysis data, including original raw reads and intermediate bioinformatic files beyond our standard purging period.

Optimisation

Consultation

Helping you scale and optimise your phage production with hourly-billed consultation services.

Lead the Future of Phage Manufacturing

Future-proof your GMP production today
Partner with us! Your expert quality partner in genome integrity management, staying at the forefront of regulatory requirements to support the highest quality standards throughout your GMP manufacturing.
  • De-risk your genomic integrity monitoring from day one
  • Build scalable phage production
  • Make phage production quality a strategic focus
  • Leverage digitalization and next-generation biological intelligence
Contact Us
world map phages
Contact

Let’s Talk!

Let’s start your compliance journey together! By contacting us, you will be directly connected with the developers, phage and bioinformatics experts, and quality managers of BatchQC. You can also book a demo with one of our specialists.

Ville Hoikkala
Ville
Hoikkala
Nitin Agrawal
Nitin
Agrawal
Johanna
Ekholm
Matti Jalasvuori
Matti
Jalasvuori
Thank you! Your submission has been received!
Something went wrong . Please check the fields and try again.