Source-linked investigation drafts
Preserve record identifiers and template versions as approved information becomes a draft. Make corrections and review responsibilities explicit.
Pharmaceutical software for US quality and IT teams.
For US biotech and CDMO teams, scope custom electronic-record workflows and private RAG around approved sources, access boundaries and Part 11 applicability. Compare ownership, integration and support costs alongside per-seat subscriptions before deciding what to build.
Prepare your project briefUnited States
Project context for your market.
Service targeting, not a local office.
Workflows to explore.
With your team.
Illustrative starting points, shaped around the systems and procedures you already use.
Laboratory imports with exception handling
Check identifiers, units and required values before importing results. Route rejected records to an accountable reviewer instead of silently accepting them.
Local context.
Defined responsibilities.
Part 11 applicability depends on the electronic records and underlying requirements. Assess applicable electronic-record and electronic-signature controls with your quality team; the term is not a blanket certification for pharmaceutical software.
FDA Part 11 scope and application guidanceRegulatory context reviewed 13 October 2026. Applicable controls must be assessed for each project; no regulatory certification is claimed.
Start with
a useful scope.
Project delivery and deployment are agreed individually. This page does not imply a local office.
Which electronic records fall within the intended use?
What validation evidence and security review does your team require?
What working-hour overlap and deployment model would support the project?
Ownership and validation scope for biotech and CDMO teams
Compare custom development with existing subscriptions over the full operating life: migration, validation, integrations, hosting, upgrades and support. Define electronic signatures, audit history and ALCOA+ record expectations with your quality owner. GAMP categorization follows the actual configuration and intended use; it is not assigned by the programming language.
Relevant solutions.
Pharmaceutical report automation
Investigation and analytical report workflows with source references, versioned templates, review steps and PDF generation.
Explore the workflowPharma AI & document assistants
Knowledge and document assistants for SOPs and technical records, scoped around source citations, access controls and human review.
Explore the workflowCustom laboratory software
Sample tracking, instrument data imports, review queues and QA/QC dashboards designed around your laboratory and existing systems.
Explore the workflowPlanning a project
in United States?
Resolve the scope and responsibilities before the build.
Is JUHENZA software Part 11 certified?
We do not claim regulatory certification. Applicable controls and evidence must be scoped against intended use and your quality system.
Can document search respect access permissions?
Permission-aware retrieval can be part of the project. Authentication, source permissions and retrieval enforcement need end-to-end evaluation.
Is there a US office or US-based delivery team?
This page describes a target service market, not a US office. Delivery arrangements and working-hour overlap are agreed for each project.
Working across markets?
Explore the operating context for your other teams.
India
Report automation · QA/QC · ERP integration
Explore the marketUnited Arab Emirates
Inventory systems · ERP · Quality documentation
Explore the marketSaudi Arabia
Manufacturing visibility · Enterprise integration · Quality
Explore the marketMalaysia
Laboratory software · QA/QC digitisation · Dashboards
Explore the marketStart with one
workflow worth improving.
Describe your process and save a useful project brief.
Nothing is sent automatically.