Document Control
ISO 13485 §4.2
Enforced revision history, approval workflows and effective dates. Only the current approved version circulates; every superseded one stays retrievable.
What happens
From a regulator notice to a signed document change
The Officer does the reading and the matching. Every decision stays with a named person on the audit trail.
Regulator publishes
MHRA · 09:14The platform polls the public sources for every workspace. A change lands in your Regulatory Checks list, dated, with its severity.
Assessment runs
RUN-231The change is mapped onto your controlled documents. It says plainly whether it covered every document it matched, or not.
Finding raised
SOP-012 · majorDocument, gap, reference, confidence and a current-to-suggested diff. Highlighted in the document text.
QA decides
CR-044Accept into a change request or a new version, reject, or defer. Whichever, the decision and who made it are on the record.
"No impacts found" is only ever shown for a run that finished and covered everything it matched. Anything less says so.
What it watches
The sources, and where their text may come from
| Source | What is watched | Coverage |
|---|---|---|
| EMA | Guidelines, EPAR and news | Watched |
| MHRA | Guidance and safety updates | Watched |
| EUR-Lex | MDR, IVDR and implementing decisions | Watched |
| ICH | Q-series quality guidelines | Watched |
| EudraLex Vol. 4 | EU GMP chapters and annexes | Watched |
| Harmonised lists | EU harmonised and UK designated standards | Watched |
| ISO clause text | Only from your own verified licensed copy, scoped to your workspace | Your copy |
The rules it works under
What the Officer will and will not do
| Rule | What it means for you | Status |
|---|---|---|
| Never self-attests | It never marks a document compliant. That decision is a person’s, on the approval workflow, attributable on the trail | Design rule |
| Citation grounding | A clause is cited only if its text was retrieved from a source we may read for your workspace. No retrieval, no citation | Design rule |
| Licensed text stays yours | ISO, IEC and BS EN clause text is used only from your own verified upload, in a collection scoped to your workspace | Design rule |
| Public law always on | MDR, IVDR, EU GMP, ICH and MHRA guidance are watched for every workspace without a licence | Design rule |
| Every run is on the trail | Completed, incomplete and failed assessments are each written to the audit trail against the update | Design rule |
| On demand as well | Ask for a compliance check, quality review or risk assessment of one document before it goes for approval. The result is saved on the document | Design rule |
| Regulator coverage | UK and EU sources today. FDA is not in the catalogue; ask if you need it | Scope |
Availability
Named now, ships with the Growth plan
The Officer, its regulatory checks and its actions ship with the Growth plan, which is defined and priced but not on sale yet. The Compliance plan sold today includes a read-only AI help assistant for questions about your own records, not the Officer. Early-access customers see it first.
Compliance plan
Read-only AI help assistant. The Officer is not included.
Growth plan
The Officer with regulatory checks and actions, plus change control, suppliers, equipment and complaints.
What it reads
The records the Officer works from
It reads the same controlled documents, training records, deviations, CAPAs and audits the rest of the system keeps, so a finding lands on the record it concerns.
Training Management
ISO 13485 §6.2
Role-based matrices, assignment straight from a controlled document, quizzes, and requalification tracked per person.
Deviation Management
EU GMP Ch. 1
Logged, risk-assessed, investigated and dispositioned, with a controlled path into CAPA when the investigation warrants one.
CAPA
ISO 13485 §8.5
Owned action items, due dates, and an effectiveness review that must complete before closure.
Internal Audits
ISO 13485 §8.2.4
Programme planning, checklists, findings and closure evidence. Findings raise CAPAs directly; external auditors get scoped access.