A twelve-minute walkthrough.

“Half of everything coming in is already dealt with. This person only sees what needs them.”

• Point at the “Handled by AI” tile and the review queue.
• Ask the assistant: “What needs my review?”

“It answers from approved documents, shows the exact section, and refuses when it has no grounds.”

• Ask: “What does the SOP say about temperature excursions?” Click a source chip.
• Ask: “What does the SOP say about employee holiday pay?” It refuses rather than guess.

“The AI proposes the factors. Fixed rules compute the grade and decide who looks. The auditor decides, with a reason that goes in the record.”

• Open the label reconciliation item (grade D4).
• Show the factor breakdown, the 75% confidence line and “grounded in the controlled documents”.
• Escalate it with a reason.

“Escalations go to a second person, never the same one. The signature records who, what it means and when.”

• Switch to Priya Raman (QA head) in the left menu.
• Open the escalation, choose the meaning, type the name to sign.
• Note that a risk level 4 item now waits for an executive.

“Risk level 4 (RPN 24 or more) needs the QA head and then an executive. The executive cannot sign first, and nobody signs twice.”

• Switch to Elena Vasquez (executive).
• Sign as executive, then open the evidence pack and show both signatures.

“Every AI proposal and every answer goes through fixed, versioned rules first. A failure stops it. Here is what those rules catch.”

• Show the rules and the rule-set version.
• In the Assurance lab, show a bad AI output being caught by a named rule.
• Say clearly that the regulation links are proposals awaiting review by a qualified professional.

“Old procedures are kept as history, marked superseded, and never cited as current. One approved for next year is not used early.”

• Open the deviation SOP and its version history.
• Open the old version to show the Superseded banner.
• Ask the assistant how many working days an impact assessment takes: five, from the current version.

“Two ICH Q9 ideas are fixed rules: risk is scored on defined scales, and formality must match the risk.”

• Show the A1 to D4 grid with live counts.
• Point at a box marked “below required”: it always goes to a person.
• Open “How a record is handled” to show the whole five-step path.

“A risk goes down by doing something that is recorded, not by typing a smaller number. Accepting what remains is an electronic signature.”

• As the auditor, apply a measure to an item and describe what was done.
• Switch to the QA head and sign the residual risk.
• Open the item’s report to show the measure and the signature.

“Missing information is asked of a named team. The item stays blocked until they answer.”

• Switch to Sam Okafor (team member).
• Answer the supplier question.
• Switch back to the auditor and show the item return to the queue.

“This is what runs all day: records flow in from the quality systems and are assessed as they land.”

• Switch the “Live feed” toggle on the console and watch records arrive and route.

“Every record is placed on the defined process, tied to company controls, and mapped to the regulations. Gaps are shown, not hidden.”

• Process map: stages and what needs a person.
• Controls and validation: the regulation gap, and IQ / OQ / PQ status linked to live items.

“Evidence the AI agrees with experts, with its misses shown, and a value model anyone can adjust.”

• Say clearly the data is illustrative until the pilot.
• Move the calculator’s sliders to match their team.

“Every AI call is listed. The safeguards are verified against the running system, not just described.”

• Show the live chain verification and the audit trail export.