For pharmaceutical manufacturing

The planner that knows how pharma work actually gets done.

Describe a change in plain English — replace a filter, update a procedure, qualify a new utility — and the plan comes back with the right safety questions baked in. Is this in a controlled cleanroom? Does it need a deviation report? Do you have to update batch records? Surfaced automatically. Works for teams with a formal quality system and for teams without one who need structure that respects good manufacturing practice (GMP) without the six-figure software. Full quality-system workflow modules ship in the Professional tier (Coming Soon).

The regulations you’re accountable for

Your team already lives under these. Generic PM tools don't know they exist; we built our planner to treat them as first-class citizens.

  • FDA 21 CFR Part 11 Electronic records and signatures — our audit trail is signable and exportable.
  • FDA 21 CFR 210/211 cGMP for finished pharmaceuticals — change control + deviation handling.
  • ICH Q9 / Q10 Quality risk management — risk factors surfaced on every plan.
  • EU Annex 15 Qualification + validation — change impact on validated systems flagged.

What generic PM tools miss

Asana and Copilot will happily generate a plan for “swap the HVAC filter in room 204” that reads like any office task. They won't ask whether room 204 is a classified cleanroom, whether the filter change is a qualified operation, or whether a deviation report needs to precede the work.

If you have a QMS (TrackWise, MasterControl, Veeva Vault), you know those things live over there — and that it takes 30 minutes to open a formal change record for a 10-minute job. So the small stuff bypasses the QMS, and that's where the audit findings come from.

If you don't have a QMS yet — smaller facility, contract manufacturing, early-stage biotech — you need structured planning that respects GMP without the six-figure system. This is that. Use it for day-to-day project work, and the audit trail + risk flagging is already built in when you need it.

What changes when you use ChangePilot

Items below are tagged Available today or Coming Soon so you know exactly what ships in v1 vs what’s on the Professional-tier roadmap.

  • Plain-English scoping that speaks GMP

    Type “replace the Pall 0.2μm filter on fermenter 3” and the planner pulls out the equipment + procedure + the scoping properties (criticality, last service, classification context) that a GMP coordinator would ask about — not the generic ones a task manager would. Available today.

  • Audit-trail PDF an inspector can read

    Every status change, every approval, every evidence upload — one-click PDF export with user + timestamp + justification. The same PDF an FDA or EMA inspector would expect to see for the underlying project record. Available today. (Formal deviation-report + PQR workflow ships in the Professional tier — Coming Soon.)

  • Built for the 200 small changes, not just the quarterly big ones

    Team tier ($49/mo) is unlimited projects. Your incumbent QMS charges per change record and takes 30 min of data entry to open one — so small stuff bypasses it, and that's where audit findings come from. ChangePilot is for the changes that shouldn't need the heavyweight overhead but should still have a trail. Available today.

  • Coming Soon: dedicated quality-system workflows

    Deviation reports, PQR updates, change-control approvals routed to the right reviewer — these ship as the QMS bridge module in the Professional tier. v1 customers get structured planning + audit trail today; the QMS workflow modules layer on top when they ship.

Try it — here’s a prompt that works for your world

Replace failing Pall 0.2 micron filter on Fermenter 3 in Suite A. Unit is qualified for monoclonal antibody production. Filter change requires cleanroom access, integrity testing post-installation, and a change record for QA review. Target completion in 10 business days with zero impact on the ongoing Lot 2847 production run.

Paste this into /screener/actions and compare the result to what Copilot gives you for the same prompt.

Try it with a real change from your site.

Paste an actual change you're planning this quarter. If the plan ChangePilot generates is materially better than what Asana Intelligence or Copilot-in-Planner give you for the same text, tell us. If it isn't, also tell us.

Other industries we know

Don't see your industry? The planner works for any operationally-serious team — construction, agriculture, services, even multi-department HR rollouts. Try it free.