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Supplier audit reports for pharma,
drafted for you to sign.

Your notes, photos and agenda become a draft report in your template, every finding tied to its evidence.

Hosted in the EUNever trains a model on your filesEvery change is logged
Auditor's notes · day 2
10:40 walkthrough line 3, cleaning
l. 41 no endpoint defined, released visually
10:55 training records, filling
Photo 7
Agenda 3.2
Cleaning and maintenance
Supplier SOP CL-07 · rev 4
Supplier audit reportSA-2026-014 · Rev A
1 Scope
2 Method
5 Findings
FindingGradeEvidence
5.1 No measurable cleaning endpointMajorNote l. 41Photo 7
5.2 Training records not currentOtherSOP CL-07
5.3 Residue limits met–No evidence
Lead auditor · signed 14:32
SA-2026-014.docx
MajorProposed · 5.1
No measurable cleaning endpoint
Why it matters
No residue limit, only a visual check. EU GMP Annex 15 §10.2 does not generally accept visual alone.
PIC/S PI 040-1 §4.2
Confirmed · 14:32
Drop your last audit report on it.or choose a file
EU GMP Chapter 5EU GMP Chapter 7EU GMP Annex 15ICH Q7ICH Q10PIC/S PI 040-1EU GMP Chapter 5EU GMP Chapter 7EU GMP Annex 15ICH Q7ICH Q10PIC/S PI 040-1EU GMP Chapter 5EU GMP Chapter 7EU GMP Annex 15ICH Q7ICH Q10PIC/S PI 040-1EU GMP Chapter 5EU GMP Chapter 7EU GMP Annex 15ICH Q7ICH Q10PIC/S PI 040-1

Leave the audit with the report drafted.

Upload the notes at the closing meeting. The draft is in your template minutes later, every finding pointing at the note behind it. You read it instead of writing it.

Typed notes, photos and scans, the agenda, the supplier's documents, your report template.

Audit day 2
16:05Closing meeting ends
16:12Notes, photos and agenda uploaded
16:16Draft report in your template, 8 findings
16:48Reviewed, signed, exported as DOCX
43 minutes, still on site

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Here is how Adem checks.

Every key statement is sourced or marked unsourced. Adem then proposes fixes, in its own draft or in a report you wrote.

Audit report 2025-118 · draftreviewed
5. Findings

5.1 Cleaning of the equipment was assessed as insufficiently documented.

5.2 The supplier committed to a corrective action by the end of the quarter.

5.3 Two training records on the filling line were not current.Classification: pending

5.4 The remaining questionnaire items were assessed as met.

5.5 The quality agreement was available in its current version.

5.6 Batch traceability was checked on two examples.

8 findings
Proposed · §5.1
The finding cites no evidence; the notes hold two.

assessed as insufficiently documented. raised as a finding: no measurable endpoint is defined for the product-contact parts, and release on visual check alone is not generally acceptable under Annex 15 §10.2 (auditor's notes day 2, l. 41; photo 7).

Wording and grade stand in the report only once you accept them. Every change is logged.

Proposed · §5.3
5.3 is in the report without a classification.
OtherPIC/S PI 040-1 §4.3

On the phrase “Two training records on the filling line were not current”: a lapse in two records, not a failed control and no risk to the patient, so it stays below Major.

5.3 says pending until you confirm. Every change is logged.

Question · §5.4
5.4 and 3.2 say different things about the same questionnaire.

Section 3.2 lists the questionnaire as open, 5.4 assesses it as met. Which one holds?

Adem proposes nothing here: the answer is in none of the evidence.

Nothing about your workflow changes.

Same template, same DOCX, same sign-off. Adem takes the writing and nothing else.

Your template

Headers, footers, numbering and tables come back intact. Your template outranks our structure, down to the grading legend.

Your grading scheme

PIC/S PI 040-1 or your own house wording. Adem proposes a grade with its reason; you confirm it or change it.

Your file, your signature

The report leaves as a DOCX with your edits tracked, opens in Word like any other, and stays a draft until you sign it.

Above your QMS, not inside it

Sign in with Microsoft and you are running in minutes. Nothing to integrate, nothing to migrate. What Adem writes stays a draft until you export it and sign it, so the record still lives in your QMS.

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HostingIn Europe, GDPR compliant
Your documentsNever used to train a model
Who can see themOnly the people you invite
StandardsISO 27001 and 42001 in place, certification in progress
Every changeLogged with who and when, yours to export
DeletingOne click, and the log of what happened stays

Quick answers

Pricing, security, qualification? Ask us →

The auditor, as today. Adem drafts and proposes; it grades nothing finally and signs nothing. Every change is logged with person and time. You qualify the tool yourself; we give you the supplier assessment pack, the technical and organisational measures and the audit trail. Adem is not a validated system of record.

Yes. Your template outranks our structure: sections, numbering, wording, headers, footers and tables. For grading, Adem knows PIC/S PI 040-1 (critical, major, other), in your house wording.

Not on volume. A report costs the same work at ten audits a year or a hundred, and Adem starts at the single report. Take one finished audit and see whether the draft holds. Free.

Two or three finished audits with their inputs, one named auditor each. We draft, your auditor compares against their own report and writes a short verdict. Three weeks, free, no commitment. Anonymise the inputs if you like. A pilot comes after, not before.

No, and it is contractual. Adem runs on enterprise endpoints; your content is processed only to fulfil your request and is never used to train a model, not by us, not by our providers.

Not yet: certification for both is in preparation. The architecture was built to the 27001 controls from day one: EU residency, tenant isolation at the database layer, append-only audit log, encryption at rest. ISO 42001 governance work (model risk assessment, human oversight, lifecycle controls) is documented and open to pilot partners.

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