Regulated-first digital delivery

GMP-ready software & modern websites — with pragmatic AI/ML.

Fraser Analytics builds clean, validated-by-design systems for regulated environments, and elegant web experiences for teams that need reliability, auditability, and speed.

Annex 1 / Annex 11 / Annex 22 mindset Data integrity & audit trails Django • APIs • Dashboards AI-ready pipelines

Services

GMP software & validation support

Build or improve systems used in production environments with a quality mindset: roles & permissions, audit trails, data integrity, SOP-aligned workflows, and documentation that stands up to scrutiny.

  • URS/FDS, risk-based requirements
  • Access control & auditability
  • Reporting for periodic review

Web development & product delivery

Fast, accessible, and brand-consistent websites and web apps with performance, security, and maintainability built in.

  • Marketing sites & documentation portals
  • Internal tools & admin interfaces
  • CI/CD and environment parity

Applied AI / ML (pragmatic)

AI that supports operators, trends quality data, and reduces administrative load — designed with controls, traceability, and “human-in-the-loop” governance.

  • Trend analysis & anomaly detection
  • Forecasting & predictive indicators
  • RAG-style knowledge assistants (where appropriate)

GMP focus

Software for production is different: controls, evidence, and repeatability matter.

Validation-minded by design

I design features so they’re easy to specify, test, and defend: clear roles, controlled configuration, robust logging, and predictable behaviour.

Audit trails
who / what / when / why
Access control
least privilege, approval flows
Data integrity
ALCOA+ mindset

Cleanroom-friendly product thinking

Interface and workflow choices that respect the reality of controlled areas: quick interactions, clear status, minimal typing, and mobile-friendly layouts.

  • Low-friction approvals and sign-offs
  • Exception handling that creates usable evidence
  • Exportable reports for review & trending

AI / ML, safely

Useful intelligence without turning your quality system into a black box.

Quality analytics

Operator / process trending, defect categorisation, and leading indicators to support coaching, CAPA prioritisation, and continuous improvement.

Best for: fresh-to-maturing datasets, Excel-first environments.

Automation & assistants

Draft summaries, create structured records, and answer “where is it / what changed” questions against approved procedures and controlled documents.

Best for: SOP navigation, governance packs, training support.

Governance & controls

Sensible model boundaries, change control, prompt/data logging, and validation strategy planning so AI becomes auditable and manageable.

Best for: regulated teams exploring first AI deployments.

Rule of thumb

If AI influences decisions in GMP, we design for transparency: versioning, monitoring, approval thresholds, and “human-in-the-loop” controls.

How I work

Agile delivery with regulated discipline: ship value while maintaining evidence.

01

Discovery

Goals, constraints, data reality, stakeholders, and what “good” looks like.

02

Requirements & risk

Lightweight URS/FDS, threat model, validation impact, and acceptance criteria.

03

Build & iterate

Small releases, test coverage, auditability, and feedback from real users.

04

Operationalise

Docs, training, support model, and change control to keep it compliant.

Contact

Tell me what you’re building, where it will run, and what success looks like.