USE CASE / AUDIT AND DEVIATION REPORTS
Audit, deviation and response reports
that state their basis.
An auditor has written the observations. Cite proposes the regulation, industry practice and internal procedure behind each one, or a fuller write-up from a terse note, and the auditor accepts, edits or declines every line. The same works for a deviation report or a response to an audit or inspection.
Runs on RegLens Cite
THE SITUATION
A supplier audit of a cloud LIMS vendor has ended, and the auditor's notes are short. Before the report goes to the supplier, each observation needs its basis stated, so that an auditee who pushes back is answered with the requirement rather than an opinion. Looking up the same regulations for every report is where the time goes.
- No AI governance for the AI features added in this release.
- GxP training not documented for support staff.
- Users report the same kind of defect repeatedly; no trend review.
- Customers not notified of changes before release.
HOW IT RUNS
Who does what.
Each step is marked by who acts: your SMEs, the AI, or the record that remains.
-
YOUR SMEs
Add the report
Upload the draft report or paste the observations. Cite splits it into numbered items, and you leave out anything that is not an observation, such as the audit scope.
-
YOUR SMEs
Choose how much help you want
Cite only keeps your wording exactly as written and proposes citations. Cite and refine also drafts a fuller write-up of each item: condition, criteria, risk and recommendation.
-
AI ASSISTS
Get proposals for each observation
Each observation is searched on its own, across regulations, guidance and your own procedures. Regulation and industry practice are labeled apart. Paywalled standards you select, such as GAMP 5, are cited from the model's knowledge and marked to verify against the current text.
-
AI ASSISTS
Refine a terse note without adding facts
In refine mode the condition uses only what you wrote. A detail your note does not give, such as the system name or version, is left as a placeholder for you to fill. Classifying each observation stays with the auditor.
-
YOUR SMEs
Accept, edit or decline each line
Every proposal is its own decision, and the cited passage opens beside it. A line whose passage shares little wording with the sentence put on it, or that draws a conclusion the source does not state, is flagged for you to check.
-
THE RECORD
Keep the record of your decisions
The finished report holds your text and the lines you accepted. It is saved with a log of every proposal and what you did with it, by whom and when, and exports to Word or PDF.
WHAT YOU HAVE AT THE END
Evidence you can show.
- The report in your own words, each observation carrying the requirement and practice behind it, exported to Word or PDF
- A decision log of every proposed line: accepted, edited or declined, by whom and when
- A closing note in the report stating how many proposals were accepted, edited and declined
- A flag on any line whose cited passage may not support it
Qualisera supports your quality system. It does not replace your quality unit's review, approval or validation responsibilities.
MORE USE CASES
Assess a regulatory change.
Find what changed, which procedures it touches, and review each one against the new rule.
Read the use case ↗REGLENS / ENFORCEMENTSStay inspection ready.
See what FDA and EU regulators have cited recently, and test your own procedures against it.
Read the use case ↗TMS / VALIDATIONValidate a vendor release.
Assess the release, test hardest where the risk is, and show the evidence.
Read the use case ↗REGLENS AGENTS + TMSStandardize your documents.
Department agents for governance documents and project templates for validation, so every document starts from the same standard.
Read the use case ↗SEE IT IN YOUR WORKFLOW
Walk through this scenario.
Evaluate it properly.
Tell us which scenario is closest to your team's work, and we will walk through it in a tailored demo.