Audit-Ready SOPs, Work Instructions and Validation Records for Manufacturers.
You send the raw material — a recording, a rough draft, a walk-through of how it's actually done. You receive a structured, toleranced, audit-ready document written by an engineer who knows what a reviewer will look for.
Five documents, one standard.
- 01 Standard Operating ProceduresMost requested
Step-by-step procedures with parameters, tolerances, sign-offs and records — the operating backbone of a line.
- 02 Work instructionsOperator-facing
Visual, task-level guidance built for the floor — unambiguous enough to onboard in days, not months.
- 03 FAT / SAT & commissioningEquipment startup
Acceptance and commissioning protocols that get new equipment qualified and running on schedule.
- 04 DFM & design reviewsPre-production
Manufacturability assessments — tolerances, draft, fixturing, failure modes — before tooling money is spent.
- 05 Validation & quality recordsAudit-ready
IQ/OQ/PQ protocols, PFMEA, in-process controls and inspection standards aligned to ISO 13485:2016 and FDA process validation guidance.
What we caught that the notes left out.
Same source notes, two outputs. A transcriber gives you the left column. An engineer gives you the right — and the right column is the one that survives an audit. Toggle the engineering on.
"Swap the mould, bolt it in, set the temps off the last sheet, run a few shots and if they look ok we're good to start the batch."
One exchange. Then you get the document.
You send raw material
A recording, a rough draft, a marked-up drawing, or a 20-minute walk-through of how it's really done. We work from your format — no template for you to fill in.
One round of questions
We scope it, quote it, and ask one focused round of engineering questions if needed. No kickoff calls, no discovery theatre. You approve the scope before we write.
You receive the deliverable
A finished, formatted, audit-ready document in your house style — typically within five business days. One round of revisions included.
Fixed scope. Quoted before we start.
- One SOP, work instruction, or protocol
- Scope & price agreed before any work
- One round of revisions included
- Delivered in your document standard
- Clear a backlog of procedures & records
- Priority turnaround, predictable monthly cost
- Consistent house style across every document
- Pause or stop any month
Frequently asked about engineering documentation.
How long does it take to write a manufacturing SOP?
A single SOP or work instruction typically takes three to five business days from receipt of your source material. That material can be a recording, a rough draft, or a process walk-through. More complex procedures with multiple sign-off levels may take up to seven days. Turnaround is agreed in the scope before work begins.
What information do I need to provide to get a document written?
Any raw material works: a voice recording of how the process is actually done, a rough draft, a marked-up drawing, or a 20-minute walk-through video. You do not need to fill in a template. The engineer asks one focused round of questions after reviewing your material, then writes the document from that.
Will the documents pass an ISO 13485 or FDA audit?
Documents are written to the standard used in ISO 13485 and MDR regulated environments. That includes defined parameters with tolerances, two-party sign-offs, deviation routing, and traceability to incoming material. Every clause is written as a verifiable record, not a description. Whether a specific document satisfies your QMS depends on your internal quality system; the scope review can align to your document control requirements.
What types of manufacturers do you work with?
Primarily medical device manufacturers under ISO 13485 and MDR, consumer electronics manufacturers with high-volume production lines, and industrial equipment OEMs. The background is deepest in process validation, equipment qualification, and new-product introduction, so the fit is strongest where those are the challenges.