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 briefProject context for your market.
Service targeting, not a local office.
Identify the customer security and quality reviewers, permitted hosting regions, integration sandboxes and working-hour overlap. Test account revocation and obsolete-document handling before expanding a private assistant.
Preserve record identifiers and template versions as approved information becomes a draft. Make corrections and review responsibilities explicit.
Check identifiers, units and required values before importing results. Route rejected records to an accountable reviewer instead of silently accepting them.
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.
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?
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.
Investigation and analytical report workflows with source references, versioned templates, review steps and PDF generation.
Explore the workflowKnowledge and document assistants for SOPs and technical records, scoped around source citations, access controls and human review.
Explore the workflowSample tracking, instrument data imports, review queues and QA/QC dashboards designed around your laboratory and existing systems.
Explore the workflowResolve the scope and responsibilities before the build.
We do not claim regulatory certification. Applicable controls and evidence must be scoped against intended use and your quality system.
Permission-aware retrieval can be part of the project. Authentication, source permissions and retrieval enforcement need end-to-end evaluation.
This page describes a target service market, not a US office. Delivery arrangements and working-hour overlap are agreed for each project.
Report automation · QA/QC · ERP integration
Explore the marketInventory systems · ERP · Quality documentation
Explore the marketManufacturing visibility · Enterprise integration · Quality
Explore the marketLaboratory software · QA/QC digitisation · Dashboards
Explore the marketDescribe your process and save a useful project brief.
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