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 work for a software company whose customers are regulated, and you produce the paperwork and testing evidence those customers need to prove the software is fit to use.
You maintain the supplier’s development and testing evidence, assemble validation packages customers can leverage, support customer audits of the supplier, and translate between engineering practice and what a customer’s quality system requires.
You cannot validate the customer’s use of the software — only they can, because validation is about intended use. What you can do is make it possible, and the difference between those two sentences is the entire role.
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
Inside the software supplier, facing regulated customers who must validate what they buy.
- Product development and the supplier’s own testing
- The customer’s own validation of their configured system
- Development practices that generate usable evidence
- A defined product configuration customers can reference
- Customers stating their intended use, which the supplier cannot assume
- Every regulated customer validating the product
- Sales, during customer due diligence
- The supplier’s validation package and its accuracy
- Supplier-side test evidence and traceability
- Responses to customer supplier audits
- The customer’s validation, which depends on their intended use and configuration
- The customer’s decision to accept the product
- How the customer operates the system in production
- The supplier’s quality function, where a defect affects evidence already provided to customers
- Customers, promptly, where a known defect affects their validated state
- Supplier validation packages and traceability matrices
- Test evidence and release documentation per version
- Supplier audit responses and known-defect disclosures
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.
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