[ SCENARIO · FREE · DETERMINISTIC ]
Validate a System
A configured LIMS is being implemented to replace paper worksheets. Decide how much validation the risk warrants, what the supplier’s assurance can substitute for, and what to do about an audit trail that does not capture what you assumed.
What a scenario is not
A scenario is a judgment exercise, not an assessment and not a compliance verdict. Finishing it evidences that you worked through it — nothing more — and the dimensions it scores are SPEQ’s, not any regulator’s.
You are putting in new laboratory software. You decide how much testing it needs, what you can take on trust from the supplier, and what to do when it turns out not to record something important.
GAMP 5 asks for effort proportionate to risk, complexity and novelty; supplier assurance can be leveraged where it has been assessed; and EU GMP Annex 11 with 21 CFR Part 11 set what the record itself has to be able to show.
Validation effort spent uniformly is validation effort wasted. The question is never how much testing — it is which risks the testing is answering, and whether the record will still be readable as evidence in five years.
You are the validation analyst on a configured LIMS replacing paper worksheets in QC.
The project has a date. Each choice changes what you find next.
The system is a commercial product with significant configuration. The project manager asks how much validation it needs.
This is a judgment exercise, not a quiz: your choices change the situation. It is scored across scope · verification · dataIntegrity · governance — the same dimensions an inspector effectively weighs when they follow the thread of a real deviation. There is no compliance verdict here; the debriefs explain consequences.
WHAT THE CORRECT PATH RESTS ON
The primary sources behind the debriefs. The authoritative text lives at each official source.
Finishing this exercise is recorded. What it evidences — and the things it does not — is set out against the published standard.
What this evidences →DO IT FOR REAL
- HOW-TO GUIDEHow to Validate a Computerized System →Validate in proportion to risk, complexity and novelty.
- TEMPLATEComputer System Validation (CSV) Plan →Set the validation approach down before testing starts.
- HOW-TO GUIDEHow to Set Up Audit Trail Review →Make sure the audit trail shows what you need it to.
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