Planning validation around risk and checking the records it produces.
01 · Context
Planning validation around risk and checking the records it produces.
The problem
A test record needs to show what was checked and whether the record has changed. Planning the checks also means deciding which failures carry the greatest risk.
My role
I built this demonstration to apply ideas from my pharmacy studies, including risk assessment, traceability, and documentation, to software validation.
02 · Engineering decisions
How it works.
- 01Use a risk engine to guide validation work.
- 02Capture evidence with SHA-256 sidecars.
- 03Exercise audit and electronic-signature behavior in a demonstration QMS.
- 04Package reproducible checks with Docker.
- Risk assessment
- Validation checks
- Evidence capture
- Integrity review
03 · Quality strategy
How I tested it.
The repository includes scripted tests, evidence-integrity checks, and demonstration quality-management workflows.
04 · Result & reflection
Results so far.
A working validation demonstration with test records and integrity checks available in the repository.
Scope & limitations
This is a portfolio demonstration, not a validated pharmaceutical production system or a compliance certification.
What I learned
A checksum helps detect changes to a record. Understanding that record still requires knowing which check produced it and what the result means.
