Data integrity (ALCOA+)
Scheduling records stay attributable, legible, contemporaneous, original, and accurate, with completeness, consistency, endurance, and availability carried through the full record lifecycle.
Trust Center
Adaptive Scheduling, purpose-built for regulated manufacturing.
Bodhee is enterprise software for Adaptive Scheduling in regulated (GxP) process manufacturing. It runs alongside your ERP, MES, LIMS, and CMMS instead of replacing them. Regulatory compliance is a property of the validated system at your site; Bodhee provides the technical and documentary controls that support GxP-relevant use.
- ISO 27001-certified ISMS
- Audit-trail-aligned with 21 CFR Part 11 and EU GMP Annex 11
- GAMP 5 Category 4
GxP control areas
Five control areas that support GxP-relevant use.
Where regulated workflows touch scheduling, Bodhee provides the controls and evidence your validation team expects.
Audit trail
An append-only, write-once event history. Every change separates the system actor from the named user and captures the reason for change, so reviewers can reconstruct what happened and why.
Role-based access control
Named accounts with SSO and SAML, segregation of duties, and least-privilege roles, so access maps to responsibility and stays reviewable at any time.
Electronic records
Durable, GCP-hosted records with configurable retention that you set to match your record-keeping policy.
Controlled change management
Automated re-solves, operational changes, and master-data updates move through environment promotion, keeping change controlled and traceable.
Standards alignment
Aligned to the standards your auditors know.
Bodhee is designed to support these frameworks. Compliance is achieved by the validated system at your site, not by the software alone.
21 CFR Part 11
Designed as a closed system with Subpart B controls, audit-trail-aligned with 21 CFR Part 11. Electronic signatures are not supported by design; they are executed in your systems of record such as MES, eBR, QMS, and LIMS.
EU GMP Annex 11
Audit-trail-aligned with EU GMP Annex 11 for computerised systems used in GxP-regulated operations.
GAMP 5 (Category 4)
A configured product under shared validation responsibility. Neewee provides validation-support material: risk-assessment inputs, requirements traceability, test scripts, test evidence, and IQ, OQ, and PQ support for dedicated-tenancy deployments.
Security & privacy
Security you can verify.
ISO 27001 certifies our whole-organisation information-security management system. Cloud-infrastructure attestations are inherited from Google Cloud Platform, not claimed as our own.
Certified
ISO/IEC 27001
Certified ISMS, whole-organisation scope
Built on
Google Cloud Platform
ISO 27001 and audited attestations, inherited
Controls
Encryption
At rest and in transit
Customer-managed keys
CMK available
Dedicated tenancy
Single-tenant data plane
Data residency
Customer-specified GCP region
GDPR
Supported, DPA on request
Penetration testing
Regular cadence
Release governance
Controlled change, on a predictable cadence.
Controlled SDLC and quarterly releases
Bodhee is developed under a controlled software development lifecycle governed by our ISO 27001 ISMS, on a quarterly release cadence. Customer UAT approval gates production, and defect fixes pass through the same UAT gate.
Validation-impact evidence
Every release ships with release notes and regression evidence so your validation team can run a validation-impact assessment before promotion.
Audit readiness
Ready when your auditors are.
In-product, self-service
Review and export the audit trail, run user-access and configuration reviews, and export evidence directly in the product.
Supplier assessment
A supplier qualification pack and audit questionnaire, the ISO 27001 certificate on request, reliance on GCP attestations for the infrastructure layer, and right-to-audit by prior agreement.
Security, compliance, and certifications, in depth.
Detailed answers on data isolation, residency, SSO, access control, the audit trail, and DPA and GDPR coverage.
Bring your validation team.
We will walk your risk, quality, and IT stakeholders through Bodhee's controls, evidence, and supplier qualification pack, and answer the questions your auditors will ask.