Guide: what the draft Annex 22 requires of AI in GMPRead the guide

CNP: Gutis's new product committee leaves the spreadsheet behind and tracks its product portfolio in real time

Gutis, a pharmaceutical company in Costa Rica, needed its New Product Committee to stop reviewing an Excel workbook line by line. The ComplAI team built it a tool to keep all its products under control in real time.

  • Client: Gutis
  • From the review to the committee in nine days
  • AI copilot

The committee decides which medicines are developed

Gutis's New Product Committee (CNP, for its Spanish name) follows every new product from feasibility to market launch: pharmaceutical development, stability studies, clinical studies, marketing authorization, transfer and commercialization. It is one of the processes that support GxP: it does not manufacture or release anything, but it coordinates the work of many departments and decides when each product reaches the patient.

The need

The committee was deciding on an Excel workbook that nobody kept up to date, and it needed this solved in days, not months.

The committee reviewed a tracking workbook in Excel line by line. Dates were typed by hand into cells, including each product's market launch date, and nothing ensured that a date change left a record of who made it or why.

On top of that, the real date of an activity was only fixed in the workbook when someone marked it as finished, and that almost never happened. Simply comparing dates painted nearly the whole portfolio red: an apparent delay of hundreds of days could just mean that nobody had closed the activity.

It did not need a validated system. It needed the committee to be able to trust what it saw, and as soon as possible. Gutis asked for five things:

A visual summary

See the whole portfolio at a glance: how many projects are late, how many are on track and which phase each one is in.

From phase to plan

Drill down from the phase to the project and from the project to its plan, down to the specific subtask.

A traffic light for delays

Know what is late, by project and by department.

The launch date, always in view

At every level, from the portfolio to each project's page.

Nothing changes without a trace

Every date that moves, with who moved it, when and why.

The solution

An application where projects live with their plans, owners and dates, and tracking that is computed every time someone opens the screen.

  • Coordination and committee
  • The teams
  • The panel

01 · Coordination, committeeThe project is set up: a published template and the start date are picked02 · The panelLays out the whole plan by stage, with its dates in working days, and sets it as the commitment to the committee03 · The teamsEach manager assigns their team's subtasks, with one or two owners each04 · The panelComputes the traffic light for every subtask and every project: overdue, due within five working days, on track or not enough data05 · The teamsEach owner closes their work with the date it was finished, or records how much is done06 · The panelSends each owner a single email a day with what is overdue and what is due soon07 · The teamsAn owner proposes moving a date08 · The panelShows which subtasks it drags along and whether it moves the market launch, before saving anything09 · The teamsConfirms with a written reason, which the database also requires10 · The panelOpens the session with a computed agenda: what has moved, what is due before the next one and what has had no news for weeks11 · Coordination, committeeThe committee reviews project by project, the commitment against the forecast, and the minutes are validated12 · The panelKeeps a snapshot of what was seen, turns each agreement with an owner and a date into a subtask and emails the minutes to the committee

  1. 1. SetupCoordination, committeeThe project is set up: a published template and the start date are picked
  2. The panelLays out the whole plan by stage, with its dates in working days, and sets it as the commitment to the committee
  3. The teamsEach manager assigns their team's subtasks, with one or two owners each
  4. 2. TrackingThe panelComputes the traffic light for every subtask and every project: overdue, due within five working days, on track or not enough data
  5. The teamsEach owner closes their work with the date it was finished, or records how much is done
  6. The panelSends each owner a single email a day with what is overdue and what is due soon
  7. 3. Date changeThe teamsAn owner proposes moving a date
  8. The panelShows which subtasks it drags along and whether it moves the market launch, before saving anything
  9. The teamsConfirms with a written reason, which the database also requires
  10. 4. Committee sessionThe panelOpens the session with a computed agenda: what has moved, what is due before the next one and what has had no news for weeks
  11. Coordination, committeeThe committee reviews project by project, the commitment against the forecast, and the minutes are validated
  12. The panelKeeps a snapshot of what was seen, turns each agreement with an owner and a date into a subtask and emails the minutes to the committee

Everything stays on record: who moved which date, when and why. Validated minutes are never rewritten: they are corrected, and the previous version stays on record.

Templates that lay out the plan

Each project starts from a published template that lays out the plan by stage, from feasibility to commercialization. Correcting a template means publishing a new version, and each project keeps the one it started from.

Dates in working days

Deadlines are counted in working days against Gutis's work calendar, except for calendar waits, such as stability chambers or an authority's deadlines. Moving a date drags the ones that depend on it, and the panel shows this before you confirm.

A traffic light that makes nothing up

Red if a subtask is past its date and still open; amber if it is due within the next five working days; green if nothing is overdue. And gray when it is not known, because gray is not a soft red.

The commitment against the forecast

In each project's Gantt chart, every subtask has two bars: in gray what was committed to the committee and in color what is forecast today. The delay is the tail sticking out to the right, with its days written next to it.

An AI copilot that only reads

The committee asks about the portfolio in plain language and the copilot answers, including charts and Excel files whose figures are computed by the panel, not by the model. It changes nothing: moving a date is still up to a person.

Benefits

What changes for the committee and for each team when the data lives in one place.

More control, in real time

The status of every project is computed when the screen opens, not when someone updates a workbook. What is overdue shows the same day, with its days of delay, by project, by team and by person: nobody has to wait for the committee meeting to know what is running late.

One figure, on every screen

The status of a subtask comes from a single rule, the same on the home page, in "My tasks", in the Gantt chart, in the reminders and in Excel. A number that differs between two screens destroys trust in both.

Every change, with a reason

Moving a date requires a reason, and the database requires it too. Who moved what, when and why stays on record, and the committee sees the deviation from the commitment.

Meetings that start prepared

Every session opens with a computed agenda. Agreements with an owner and a date become tasks, and the minutes go out by email when they are validated.

Everyone sees their own

The new product portfolio is confidential: only the committee and whoever coordinates the program see all of it, and every screen checks this, not just the menu. Each manager sees their team and each person, their tasks.

Also

  • Two figures for two questions: plan completion, weighted by the duration of each subtask, and commitments met, measured against the committed date and not against the one that has kept moving.
  • A simulator for the question the committee asks out loud, "what if this slips?": how many subtasks it drags along and how far the market launch moves, without saving anything.
  • Contracted clinical studies, with the deadline signed with the laboratory and a warning when delivery comes later than the plan assumes.
  • A launch calendar with the date that comes from the plan, next to the one shown to the committee.
  • Each owner gets at most one email a day, and only when there is something to tell them. Whatever is overdue and has no owner goes separately to whoever coordinates the program.
  • It counts days in Costa Rica time, even though the server is in another time zone: what is due today does not show as overdue in the afternoon.

“We needed to leave the spreadsheet behind as soon as possible, and we could not wait months for a new development project. Nine days after reviewing our processes, we were already presenting the panel to the committee, with the projects inside and the dates computed. And the pace did not slow down: whenever we asked ComplAI for a change, we had it within days, sometimes the same day.”

Greivin Mora SAP Competence Center Manager at Gutis

Let's talk about your process

If your committee or any process that supports GxP lives in a spreadsheet, tell us which one and we'll tell you how we would approach it.