IndustriesPharma engineering and quality

Every calibration, signature and SOP step, inspection ready.

One controlled system for maintenance, calibration, SOP execution and deviations, with an audit trail that is complete the moment the work is done.

saturnIts rings hold everything in line
Request a diagnosisHow we work
Saturn and its rings
Before and after

The same business, on one system.

Left is how most teams work today. Right is the same business on &n.

Today

A formulation facility

  • PAPERSOP sign-off sheets, two signatures each
  • EXCELCalibration due dates
  • LOGBOOKEquipment usage, by hand
  • EMAILVendor service reports as PDFs
  • BINDERDeviation records
  • MEMORY“I think B-07 is due next month”
  • PRINTERBatch records printed to be signed
1 day a weekof QA time spent assembling audit evidence
On &n

One controlled engineering system

MaintenanceCalibrationSOP executionDeviationsAudit trailVendors
  • Schedules calibration before it expires
  • Chases the missing second signature
  • Builds the audit pack on request
Inspection readywith a complete trail for every action
What we build

One controlled engineering system.

Each module is shaped around your process in the diagnosis. You start with the ones that remove the most rework.

From many places to onePharma engineering
Today · 7 placesPaperExcelLogbookEmailBinderMemoryPrinter
One controlled engineering system
On &n · 6 modulesMaintenanceCalibrationSOP executionDeviationsAudit trailVendors

Preventive maintenance

Schedules per asset, work orders on the technician’s device, history in one place.

Calibration

Every instrument, its due date, its certificate and its out-of-tolerance history.

SOP execution

Steps completed and signed in order, with the second signature requested automatically.

Deviations and CAPA

Raised where they happen, investigated, closed and linked to the asset.

Electronic logbooks

Equipment usage and cleaning logs recorded as the work is done.

Audit trail

Who did what, when and why, for every record, protected from edits.

AI that asks firstPharma engineering

AI drafts. Your people decide.

WAITING FOR APPROVALCalibration due · balance B-07Slot proposed for Thursday, before it expiresApprove · Edit · Decline
  • Schedules calibration before it expires. The engineering head approves the schedule.
  • Chases the missing second signature. The named reviewer still signs it themselves.
  • Builds the audit pack on request. QA reviews it before it leaves the building.
Without itAutomation that acts on its own, with no one accountable.What you getNothing happens until a named person approves it. Every decision is logged.
Standards

Built for the rules you are judged by.

Built for electronic records and signatures as regulators expect them, and delivered with the documents validation needs.

Designed for
  • GMP
  • 21 CFR Part 11 and EU Annex 11: electronic records and signatures
  • GAMP 5 approach to validation
Works with
  • Your ERP and asset register
  • Vendor service reports
  • Single sign-on and your user directory
  • Your own servers, if required
Proof

Built from zero, running every day.

Pharma engineeringEngineering evidence, audit ready.
Preventive maintenance, calibration, SOP execution and audit logs in one controlled system.Read the case study →

Questions we hear first.

Do you provide validation documents?

Yes. We work to a GAMP 5 approach and prepare the specification and qualification documents with your QA team.

How is the audit trail protected?

Entries are recorded automatically and cannot be edited or deleted by users. A correction is a new entry with a reason, and the original stays visible.

Can it run on our own servers?

Yes. We can deploy inside your network or in a private cloud, as your IT and QA policies require.

Can we start with one area?

Yes. Most sites start with calibration or preventive maintenance and add SOP execution once the team is comfortable.

Where it starts

Every engagement begins with a two-week diagnosis.

One workflow, two weeks. You keep the map either way.

Request a diagnosisWhat the diagnosis covers