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Sequences

Work that runswhile you’re away.

Sequences run saved prompts, orchestrations and Surface Actions on a schedule, or the moment something changes: an email arrives, a meeting ends, a supplier receives a Form 483. Anything sensitive waits for your approval.

Larkspur Biologics · Sequences
Supplier 483 watchActive

When

FDA posts a Form 483 for a approved supplier

40 suppliers · 57 sites

Only if

Observations mention sterility or aseptic processing

Checked on each posting

Then

Run Supplier Risk orchestration

Updates the Supplier risk Surface

Then

Draft notice to Quality

Needs approval before sending

07:00Checked FDA 483 postings · 0 new

Mostoperationalworkstartswithsomethingchangingsomewhereelse.Sequenceswatchforthechange,dothefirstpassofthework,andbringyouonlywhatneedsadecision.

Capabilities

What Sequences does

  1. 01

    Schedules

    Run once at a set time, or on a recurring schedule: the Monday supplier review, the month-end quality metrics, the quarterly program readout.

  2. 02

    18 trigger types

    Email received or replied, calendar changes, meeting ended, transcript ready, Linear issues and comments, Surface records changed or due, orchestrations completed or failed, files processed and regulatory changes published.

  3. 03

    Regulatory alerts

    Hear when a approved supplier receives a Form 483, Warning Letter or OAI classification, when a Phase 1 oncology trial registers, or when USP publishes a revision.

  4. 04

    Approval by default

    Sending email, writing to calendars, updating Salesforce or Monday.com and team messaging pause for human approval. Optional pre-approvals expire.

  5. 05

    Only tell me when

    Conditional notifications in the app, by email or by push, quoting the evidence that triggered them and suppressing repeats.

  6. 06

    Runs what you've already built

    A Sequence can run a saved prompt, an orchestration from the library or your own, or a governed Surface Action.

Regulatory alerts

Know about the 483 before the supplier calls.

Tell Sofie which suppliers and sites matter. When a Form 483, Warning Letter or OAI classification is published for one of them, a Sequence reads it and notifies you with quotes from the official source.

  • Recall, shortage and enforcement feeds checked every six hours
  • “Regulatory change published” as a trigger for any Sequence
  • Evidence quoted in every notification
Larkspur Biologics · Regulatory Intelligence
Compare Keller, Sato and Northwind for a sterile injectable: FDA and EU inspection history and recurring 483 themes.

Researching across 9 authorities

Matched 3 companies to 7 sites
Read 11 FDA inspection outcomes
Read 4 published 483s
Checked EU GMP status
Ask about any regulator, site or product…

Approvals

Nothing leaves without a person.

Unattended work is useful until it sends the wrong email. Sequences pause at every sensitive step, show you exactly what is about to happen, and continue only when someone approves.

  • Email, calendar, Salesforce, Monday.com and team messaging need approval by default
  • Optional pre-approvals that expire
  • Runs wait, rather than fail, while approval is pending
Sequence · Supplier 483 watch

Approval needed

Run paused
Send emailvia Outlook

To supplier.quality@keller-pharma.example

Subject Request for 483 response and CAPA timeline

Approve and sendEditDecline

Triggers

From meeting to minutes, without a reminder.

Connect the events your teams already react to. A finished kickoff drafts its minutes, a CAPA nearing its effectiveness check prompts the owner, and a failed orchestration tells the person who built it.

Sequences · Triggers

    Meeting ended

    Draft minutes from the Tech Transfer notes template

    Transcript ready

    Update action items on the program tracker

    Email received

    From a client, about a change request

    Surface record due

    CAPA effectiveness check due in 7 days

    Regulatory change published

    EU GMP Annex 1 or 21 CFR 211

    Orchestration failed

    Notify the owner with the failing step

00:00:00:00

Product film · Work that runs on its own · In production

Sequences

1:00 target
trigger types, from email and meetings to regulatory changes
18
between checks of recall, shortage and enforcement feeds
6 hrs
notification channels: in-app, email and push
3

Questions

Frequently asked

Are Sequences email campaigns?

No. Sequences are background automations that run saved prompts, orchestrations or Surface Actions on a schedule or trigger. Sending an email can be one step, and it waits for approval by default.

What needs approval?

Sensitive tools, including sending email, calendar writes, Salesforce, Monday.com and team messaging, require human approval by default. You can grant a pre-approval that expires.

How do I avoid noisy alerts?

Use conditional notifications: describe when you want to hear about something. Sofie quotes the evidence that met the condition and suppresses repeats.

Which regulatory events can I watch?

Sequences can trigger when Regulatory Intelligence publishes a change, for example a Form 483, Warning Letter or OAI for a approved supplier, a new trial registration, or a USP revision notice.

Start with one workflow.
Measure it. Then expand.

In a working session we choose a priority workflow, define your standards and review points, and agree how to measure speed, quality and capacity. Then you evaluate Sofie's work before deciding whether to expand.