IE QMS
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Built for SaMD & ACNU teams

Quality management that remembers everything

IE QMS is Idea Evolver's quality system for software as a medical device. It follows every controlled document from first keystroke to effective SOP — and keeps a record that can retell the whole story, signature by signature, the day an auditor asks.

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The life of a controlled document

Follow SOP-012 from first draft to superseded

Every controlled document in IE QMS walks the same road — and every step of it leaves a record no one can quietly edit later.

  1. Chapter One · Draft

    Someone writes it down

    Every procedure starts as words in motion. Author it in the app, or import the Word file the team already argues in — either way it becomes SOP-012 v3.0: numbered, versioned, and owned. A draft is the one place in the system where the words are still allowed to change.

    audit_log +1document.draft_created · A. Rivera

  2. Chapter Two · Review

    The team weighs in

    The draft is routed to named reviewers and approvers — no forwarded attachments, no “did you see my email?” Everyone reads the same version, and the route itself becomes part of the record: who was asked, who answered, and when.

    audit_log +1document.submitted_for_review

  3. Chapter Three · Approval

    A signature that means something

    Approval here is not a button — it's a Part 11 e-signature. It demands re-authentication, records a stated meaning, and hashes the exact content on screen. The moment it lands, the database freezes the version's text. From here on, what was signed is what stays.

    audit_log +1signature.applied · meaning: approval

  4. Chapter Four · Effective

    The SOP goes live — and gets read

    On its effective date, v3.0 becomes the procedure. Training assigns itself by role; each person acknowledges with a signature, and an effectiveness check later proves the reading actually stuck. Trained isn't a claim in this system — it's a query.

    audit_log +1training.assigned · 12 people, by role

  5. Chapter Five · Change

    The world changes. The record keeps up.

    When the process moves on, a change order opens v3.1 — with a reason, a risk assessment, and approvals of its own, linked to everything it touches. v3.0 is superseded, never erased. Nothing in IE QMS is rewritten; it is only ever succeeded.

    audit_log +1document.superseded · by v3.1 (CO-018)

Regulatory intelligence

Meanwhile, at six in the morning

Your quality system doesn't sleep in. On schedule, IE QMS sweeps the FDA guidance you care about and compares every source against its last visit. When something moves, it files a finding, drafts a gap assessment against your own SOPs, and notifies the roles who need to know.

By the time you sit down with coffee, the question is no longer “did anything change?”— it's “do I agree with the draft assessment?”

Everything a quality system owes you

One system of record from first draft to effectiveness check — no binders, no wikis, no “final_v2_FINAL.docx”.

Controlled Documents

Versioned SOPs with one source of truth. Content freezes the moment a version leaves draft, and history is never rewritten — only superseded.

Part 11 E-Signatures

Every signature records signer, timestamp, and meaning, plus a SHA-256 hash of the exact content signed — applied only after re-authentication.

Training & Effectiveness

Reading assignments targeted by role, acknowledged with a signature, and followed up with effectiveness checks — so training is provable, not assumed.

CAPAs & Change Orders

Quality events with root causes, actions, and closure evidence, linked to the documents and versions they touch.

Regulatory Intelligence

AI monitors FDA guidance on a schedule, spots changes, files findings, and drafts gap assessments against your own procedures.

Ask AI, Everywhere

An assistant that knows your quality system — ask about a procedure, summarize a guidance, or draft an analysis, with every answer traceable.

21 CFR Part 11

Integrity the application can't override

Part 11 controls aren't a settings page here — they are database triggers. The record-keeping rules hold even against the code that wrote the records, and against anyone holding an admin password. Try it, and the database answers for itself.

  • Append-only audit trail

    Every state change lands in an audit log the database itself refuses to update or delete.

  • Immutable signatures

    Signature records cannot be edited after the fact — by anyone, at any privilege level.

  • Frozen content

    Once a version leaves draft, a trigger rejects any write to its content. What was signed is what stays.

Verbatim error messages from IE QMS's own database triggers.

Eighteen months later, an auditor asks…

This is the day the whole story was written for. Every question has the same answer: it's on the record.

“Who approved this version?”

The signature: who signed, what it meant, when it happened, and the hash of the exact content they were looking at.

Answered in one click

“How do you know staff were trained?”

The training record: who was assigned by role, when each person acknowledged with a signature, and the effectiveness check that followed.

Answered in one click

“What changed between v2 and v3?”

The change order: the reason, the risk, its own approvals — linked to both versions, with neither rewritten.

Answered in one click

The record writes itself. You just do the work.

IE QMS is the Idea Evolver team's quality workspace. Sign in with your Idea Evolver Google account and pick up the thread.

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