What a role map is not
A role map is orientation — not a job description, a competency framework, or a statement of what any employer expects of you.
You help prove the software used to make and test products works properly and keeps honest records.
You write and run validation protocols, trace requirements to tests in both directions, and verify the controls that make records trustworthy — unique accounts, role separation, and an audit trail configured as claimed rather than assumed. You scope the effort to what the system does for the process and to what the supplier has already demonstrated, and you assess every change, patch and upgrade against the validated state rather than treating go-live as the end.
You are learning to make software trustworthy by evidence — so quality decisions rest on data that holds up to inspection. Two failures dominate the discipline and both look like diligence: testing every function the software has rather than the use the process depends on, and accepting the audit trail on the supplier’s word. Reverse tracing is the instrument that catches the first; switching the audit trail on and reading it catches the second.
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
Inside computer system validation, across the GxP systems that run manufacturing, the laboratory, and the clinic.
- User and functional requirements and the risk assessment
- System configuration and infrastructure qualification by IT
- A GxP system goes live in a validated state
- The records that system produces are relied on for release and decisions
- Clear user and functional requirements
- Supplier documentation and system access
- A documented risk assessment
- Quality Assurance (for validation approval and release)
- Every function that trusts the system’s data
- The validation deliverables and requirements-to-test traceability
- Verification of data-integrity controls (audit trail, access)
- Building or configuring the system
- Approving the validation — QA owns approval
- QA and the system owner
- Immediately, for any data-integrity gap or unassessed change to a validated system
- Validation plans, protocols, and reports
- Requirements traceability matrix
- Periodic-review and change-control records
WHAT THIS ROLE CAN EVIDENCE · 1
Mapped to this role in the published registry. Nothing on this site assesses them yet, so this is what the standard says the work involves — never a claim about you.
A role map is Locate, moment 2 of 5: what surrounds your work, what you own, and what you escalate. It does not teach the practice or test it. Next is Learn — the Computer System Validation pathway, then Practise in a scenario, then what any of it evidences. Skip any of them — the order does not change.
ENTERPRISE CAPABILITIES YOU WILL ENCOUNTER
The regulations and standards this pathway anchors on. SPEQ decodes and cites each one; the authoritative text lives at the official source.
- 21 CFR Part 11Electronic Records; Electronic SignaturesFDA · last revised 1997-08-20
- EU GMP Annex 11Computerised SystemsEMA · last revised 2011-06-01
- ICH Q9(R1)Quality Risk ManagementICH · last revised 2023-01-18
- ISPE GAMP 5 (2022)Good Practice Guide: Compliant GxP Computerised SystemsISPE · last revised 2022-04-01