Spen for Pharma · For Pharma operations, quality and regulatory leads

AI that increases your teams' productivity right from

Spen is compiling the batch record review for lot 2210.

Meet your teammate

Your teams get an AI teammate for every employee that prepares documentation, tracks deviations and submissions, chases suppliers and answers field requests — inside the systems you already use, while IT stays in full control.

Hikaru, quality director, on Teams

What Spen takes off your teams' plate

Your experts should be making quality and regulatory decisions, not compiling documents.

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The problem

Batch record review means hours of checking signatures, dates and values by hand.

How your team solves it with Spen

Spen checks each record against the specification and flags the entries that need a reviewer's attention.

Plug & play

Up and running in three minutes

  1. 01

    Connect your tools

    Link email, calendar, chat and the systems your team runs on. Spen requests only the access you grant.

  2. 02

    Spen learns how you work

    It learns how your company runs, how your team works and how you write, so it can act the way you would.

  3. 03

    Delegate whatever you want

    Hand off a task or a standing routine. Spen does the work, reports back and asks before anything goes out.

Proactive

Spen doesn't wait to be asked. It follows up, flags what's stuck and pushes your team towards its goals.

  • Morning summary

    Start the day knowing what matters.

  • Loose ends review

    Everything you owe, before the day ends.

  • Prepares your meetings

    Walk into every meeting with context.

  • Brief before every meeting

    Your prep, in your inbox before it starts.

  • Drafts for what’s pending

    Your replies, already started.

  • Weekly summary

    Start the week knowing what’s ahead.

  • Auto inbox

    Your inbox, sorted without lifting a finger.

  • Declines cold outreach

    Your inbox, free of offers you didn’t ask for.

  • Calendar optimizer

    Better weeks, fewer back-to-back meetings.

Missions

Give Spen an objective. It works until it's met.

You set the goal and the limits. Spen keeps at it across days and tools, and nothing reaches a customer, supplier or system without a person's approval.

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Mission 01 · Objective

No CAPA overdue

What Spen does until it's met

Spen tracks every deviation and CAPA, reminds owners and prepares the status for each quality review, until all are closed.

Runs every day. Asks you before anything goes out.

Integrations

Spen stays where your work already lives

Your team writes to Spen and approves from WhatsApp, Teams, Slack or email. Spen does the work across every tool you already run on, and connects them to each other.

VeevaSAPMasterControlOracleMicrosoft Dynamics 365SharePointDocuSignServiceNowPower BIWorkday
See all 50+ integrations →

Built for your company

Agents and integrations built around how your company works

We adapt Spen to every company. Our team builds fully custom agents, models and integrations for your processes, your systems and your industry, alongside your IT team.

Some examples of what we can build for you:

  1. 01 · QualityBatch record review modelsAutomated checks of records against specifications, validated with QA.
  2. 02 · RegulatorySubmission assemblyDocument collection and checklist validation for variations and renewals.
  3. 03 · PharmacovigilanceCase intake supportStructured intake and triage of adverse event reports for your PV team.
  4. 04 · IntegrationsQMS, LIMS and ERP connectorsVeeva, MasterControl, LIMS and SAP in one validated flow.
  5. 05 · Sovereign AIPrivate models, on-premiseModels that run inside your company, inside your validated environment.
We start with one team and one measurable objective, then scale.

Enterprise-grade
from day one.

Your data is yours. Spen never trains on customer content, isolates every workspace, and gives admins granular controls over who can do what, with which models, and against which systems.

Independently audited, deployable in your preferred region, and integrated with the identity stack your IT team already runs.

SOC 2 Type IIISO 27001

No training on your data

Your prompts, files, and outputs are never used to train foundation models — contractually and technically.

SAML SSO & SCIM

Okta, Microsoft Entra ID, Google Workspace, and any SAML 2.0 identity provider. Automated provisioning and role sync.

Workspace isolation

Each tenant's data is isolated and encrypted at rest and in transit. Customer-managed keys available on Enterprise.

Regional deployment

Deploy in the US, the EU, or APAC. VPC peering and private networking for regulated industries.

Give your experts their time back for science

Start with one process in quality or regulatory, or book a demo built around your documentation.

Meet your teammate

Spen for other industries