Integrated quality systems for regulated manufacturing
PAUL YEATMAN BSC.

QUALITY
OS

One system.
One history.
One truth.

Quality OS is a configurable, site-agnostic quality-management platform intended to provide one coherent backbone for regulated quality work rather than a collection of disconnected systems.

Sign in Development roadmap
DEVELOPMENT PROJECT // NOT COMMISSIONED
Self-hosted Configurable Controlled by design
qualityos://shared-backbone 
                 QUALITY OS
                     │
             ┌───────┴───────┐
             │ SHARED ENGINE │
             └───────┬───────┘
                     │
       ┌─────────────┼─────────────┐
       │             │             │
   DOCUMENTS      TRAINING       CHANGE
       │             │             │
       ├──────┬──────┴──────┬──────┤
       │      │             │      │
      CAPA  AUDITS         HOLDS  LIMS
       │      │             │      │
       └──────┴──────┬──────┴──────┘
                     │
          ONE CONTROLLED HISTORY
identity stable internal product = Quality OS branding installation-managed authority durable records + audit trail status development / not commissioned
DESIGN PRINCIPLE // 001

Quality is one system.
The software should behave like it.

Documents, training, change, CAPA, audits, holds and laboratory records should share controlled identity, history and relationships instead of becoming isolated islands.

01

INTEGRATE

Build quality functions on one shared backbone so relationships remain explicit and traceable across modules.

02

CONTROL

Make state, authority, provenance and audit evidence deliberate system behaviour rather than an afterthought.

03

CONFIGURE

Keep organisation, site and presentation data installation-managed while the Quality OS product identity remains stable.

04

What Quality OS is

Quality OS provides the stable product identity and shared control layer. Organisation, site, deployment and presentation remain installation-managed so the same product can be configured for different regulated environments.

05

One shared quality backbone

Common platform services keep identity, authority, evidence and history coherent across documents, training, change, CAPA, audits, holds, laboratory work and future modules.

06

Design principles

Controlled state is explicit and auditable. Historical evidence is reproducible. Replaceable tools remain adapters rather than the source of Quality OS business authority.

07

Regulated-system posture

The architecture is being designed to support durable authentication, authorization, audit trails, electronic records and electronic signatures. Design capability is not a compliance claim. Quality OS must not be described as 21 CFR Part 11 compliant, validated or commissioned until applicable technical, procedural, predicate-rule and formal validation requirements are satisfied.

08

Architecture approach

Domain modules own their business rules while shared platform services provide reusable identity, permission, audit, evidence and transaction controls. Quality OS remains the stable system identity.

09

Project provenance

Engineering provenance is retained through Git history, architecture decisions, migrations, tests and deployment evidence. Installation branding does not replace that technical authority.

PROJECT STATE

Current development status

This page intentionally remains evergreen product positioning and does not duplicate changing implementation status. This development instance is not commissioned, formally validated, or represented as compliant.

Changing implementation status is maintained on the development roadmap, which remains the repository-backed authority for current implementation state.