Your quality systems hold the record. Your team covers the gap.

The work before review and after approval still falls to a person. Botable builds and runs the AI layer that closes the gap. Every judgment call stays with your team.

Some ways to close the gap

04/04

  1. 01

    Change-order review

    Today

    Known change order issues are found the slow way: by a reviewer, after submission.

    With your AI layer

    Checks every change order for the issues that sank the last ones, and hands the author a fix-it list first.

    Human decisionWhether the change is good enough to submit for review.

    PLM · CO-4471Botable AI layer

    Change Order Admin

    4 issues found

    Affected documents on the change order

    • PN-4183 Rev D · listed
    • SOP-284 Rev B · listed
    • WI-357 Rev C · not listed
    • SOP-641 Rev C · listed

    Missing from the list

    WI-357

    revised 4 Mar, after the CO opened

    From the PLM record


    And three more

    Training, disposition, standard

    Fix and resubmitIgnore

    Document Control still approves. Nothing about that changed.

  2. 02

    Training after a document change

    Today

    Someone pulls the training report, rebuilds it in a spreadsheet, and starts chasing.

    With your AI layer

    Checks the eQMS/LMS daily, reminds people where they already work, and brings in managers before the deadline.

    Human decisionHow many reminders go out, and when a manager is brought in.

    eQMS · SOP-193 Rev CBotable AI layer

    Training notifications

    3 escalated

    Who needs retraining · 15

    AMJTRKPNDLSBMCEHTWGVLFNRHSODWQ

    Reminders sent automatically

    • 12 reminded directlyThree reminders each. Nobody on the team chased anyone.
    • 3 went to supervisorsR. Okafor · M. Lang, after the third reminder went unanswered.

    Completion posts back to the eQMS/LMS as each person finishes.

  3. 03

    Complaint intake and coding

    Today

    An analyst reads every complaint and codes it by hand, while intake keeps growing.

    With your AI layer

    Reads each complaint on intake, proposes a code, and highlights the exact text it came from.

    Human decisionThe code, and whether it is reportable.

    Complaint intake · CMP-2094Botable AI layer

    Complaint coding

    Awaiting analyst

    Complaint as received

    • Caller reports the device was used for two consecutive cycles. She states that
    • the seal detached during the second cycle.
    • No patient injury was reported.

    Suggested code

    A0704

    Seal / gasket issue

    From the highlighted text


    Reportable?

    Likely

    AcceptChange code

    The analyst confirms every code before it goes on the record.

  4. 04

    Your specific workflow

    Today

    A person carries the checks and handoffs between systems, by hand.

    With your AI layer

    We build around your rules, not ours.

    Human decisionEvery approval and every exception, held by people you name.

    Your record. Your rule. Your approver.

    The same frame, built around your process.

You set the boundary. We build inside it.

You answer four questions before we build anything. The answers are decisions on record, not settings somebody flips later.

01

Your systems

Official source

Your eQMS, PLM and LMS stay the official record. The AI layer runs alongside them, never instead of them.

02

What it may touch

Access and action

You name what it can read and what it can write back. The list is set before we build, and it does not grow on its own.

03

When the rule fits

Human approval

You decide what runs on its own and what waits for a person. What is reportable, what gets approved: those calls never leave quality.

04

When it does not

Exception path

Anything the rule does not cover stops and goes to a person you name. Nothing is handled quietly.

It runs on the systems you already own.

Examples, not a partner list. What we connect to, and what it is allowed to write back, is agreed for your build, and it stays your call.

Your systems keep their jobs. The AI layer carries the work between them.

01

eQMS

6 systems

The official record: the change, and who approved it.

  • Arena
  • MasterControl
  • ETQ Reliance
  • Greenlight Guru
  • TrackWise / TrackWise Digital
  • Veeva Vault QMS
02

PLM

6 systems

What the change actually touches: drawings, BOMs, the product.

  • Teamcenter
  • Windchill
  • Aras Innovator
  • Oracle Agile PLM
  • SAP PLM
  • Autodesk Fusion Manage
03

LMS / training

5 systems

Who is assigned, who is done, who is overdue.

  • ComplianceWire
  • Cornerstone
  • HealthStream
  • Relias
  • SAP Litmos
04

RIM / regulatory

4 systems

Regulatory records: submissions, registrations, and their history.

  • Veeva Vault RIM
  • ArisGlobal
  • Oracle Argus
  • Rimsys

Bring us the work your quality system starts and your team finishes by hand.

We map the work, build the missing step, and stay to run it as your SOPs, systems and people change.

Start with one gap