Rev 06Verification records clarifiedEffective
Rev 05Added design review cadence2026-03-02
Rev 04Scope extended to accessories2025-12-15
Rev 03Initial release under QMSR2025-08-30
Colophon (n.)
An inscription containing the details of construction — and who made it.
A Quality Management System built for agile Medical Device and Biotech teams
SOP-004 · Rev 06Approved
Design Control Procedure
MElectronically signed and bound to this content.
Someone stands behind it.
Someone stands behind it.
A LOOK INSIDE
Where SOPs, records, and signatures live.
A quality and document control system built for small, agile teams. Flexible enough to shape around how you already work, operational on day one, and audit-ready by construction.
Approved
Design Control Procedure
Establishes the design and development controls applied across the product lifecycle, per ISO 13485 §7.3 and the FDA QMSR.
1 · Purpose
This procedure defines how design inputs, outputs, reviews, and verification activities are planned, executed, and recorded under design control.
2 · Scope
THE DILEMMA
Most companies rely on one of two systems.
Neither was designed for a team of fifteen people trying to ship a device.
SOP-004_v3_FINAL.pdf
SOP-004_v3_FINAL_signed.pdf
SOP-004_v3_FINAL_signed(2).pdf
SOP-004_REV6_use-this-one.docx
scan_20260312_114522.pdf
Paper-based system
Wet signatures on a shared drive
Disparate documents scattered across folders and approvals living in email. Not searchable, not linkable, and easy for mistakes to happen — you find out which copy was current when an auditor asks.
DOCCAPANCRSUPPTRNAUD
Configuration wizard
STEP 4 OF 12 · WORKFLOW RULES
BackNext
Enterprise eQMS
Built for a company you aren't yet
Extensive time to roll out, a steep learning curve, and a dedicated administrator to keep it running — all at a price tag written for an organization ten times your size.
OUR SOLUTION
One place to author, approve, and prove.
Colophon gives your team a centralized, easy-to-use space to author documents. Every action is recorded in the audit log, and every electronic signature is bound to the content it approves.
The document lifecycle
01Draft
Draft documents like a wiki
Approachable, modern editing. Documents are authored directly in the tool — no checking files in and out, no template wrangling. Anyone who can write a doc can write a procedure.
Draft
4 · Design Verification
Verification confirms design outputs meet design inputs. Records are retained in the Design History File.
/insert table, form, or link…
Rev 05→Rev 063 changes
41
42Verification records are filed by the design lead.
42Verification records are retained in the Design History File and reviewed at each design review.
43
44
DR
02Revise
Revise together, with the history kept
Team members revise documents and contribute input directly. Every change is tracked against the edition it came from, so you can always see what moved between one revision and the next.
03Review
Route for review in a click
Send a document to the right people when it's ready. Reviewers get an email and see it waiting on their dashboard — no chasing anyone down for a response.
Send SOP-004 for review
Rev 07 draft · due in 5 days
MONotified
Marcus Okafor
Approver
DRPending
Dana Reyes
Reviewer · Engineering
JLPending
Jae Lin
Reviewer · Regulatory
Review requested
SOP-004 Design Control — from Priya Shah
Sign this document
SOP-004 · REV 07
Signer
Marcus Okafor
Password
••••••••••
Meaning of signature
Approved▾
Binds to content hash 9f2a…c7e1
04Approve
A signature bound to what it signed
When someone signs in Colophon, the signature is bound to that exact content. If a single character changes afterward, a new version is required — there is no such thing as a quiet edit after approval.
05Export
Controlled exports for vendors and auditors
When a document has to leave the system, export a PDF that carries the record with it — who approved it, when, at which revision, and against what content.
CONTROLLED COPYPAGE 1 / 9
Design Control Procedure
APPROVAL RECORD
Approved byM. Okafor
Date2026-05-12
Revision06
Content hash9f2a…c7e1
06Revisions
Every edition kept, everyone told
Revisions are versioned and logged as they happen. When a new version is approved, the people who work to that document are notified — so nobody is running last quarter's procedure.
07Audit log
A permanent record nobody can edit
Every action is written to an append-only audit log. Quality owners can trace what changed in the system over time — who did it, when, and in what order — without asking anyone to reconstruct it from memory.
TIMESTAMPACTOREVENT
05-12 14:22M. OkaforSigned SOP-004 Rev 06 · Approved
05-12 09:07P. ShahRouted SOP-004 for review
05-11 16:48D. ReyesEdited §4 Design Verification
05-11 11:15J. LinAttached V&V-217 test report
05-09 08:31P. ShahCreated draft Rev 06
03-02 13:04M. OkaforSigned SOP-004 Rev 05 · Approved
COMPLIANT BY CONSTRUCTION
Regulated-system behavior, built into the foundation.
Every controlled document carries its own verifiable provenance — author, approver, edition, date, and content hash — so when an auditor walks in, the record speaks for itself.
✓21 CFR Part 11 — electronic signatures & records
✓FDA QMSR — the modernized quality system regulation
✓ISO 13485 — clause-mapped controls
01
Immutable version history
Every edition is preserved, never overwritten. Compare any two side by side.
02
Content-bound e-signatures
Each signature is cryptographically tied to the exact content it approved.
03
Tamper-evident audit trail
Append-only and complete — who did what, when, in what order, provable after the fact.
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