1. Pharmaceuticals QMS
  2. Features
  3. Audits
Feature · Audits

Audits

Plan audit scope, assign an auditor and follow findings through their owners and due dates.

OverviewAudit findings due
Pharmaceuticals QMS · Audits

Audit findings due

Audit findings

New
AuditRequirementFindingSeverityDue dateClosed at
ADT-62216RQR-467FND-200Observation08 Oct11 Oct
ADT-49032RQR-701FND-560Minor12 Oct13 Oct
ADT-44656RQR-816FND-858Major08 Oct09 Oct
ADT-49711RQR-413FND-863Observation09 Oct10 Oct
ADT-30720RQR-715FND-421Minor12 Oct14 Oct
6 of 6 records
RQR-467Audit findings · AF-55646
Observation
AuditADT-62216
FindingFND-200
Due date08 Oct
Closed at11 Oct
Example screen with sample data

What you can do

Keep findings with the audit that raised them

An Audit has a number, scope, planned date, completion date, status and Auditor. Findings link back to that audit. Each finding records the requirement, what was found, severity, due date, closure date and an Owner. This structure lets a quality team distinguish an audit that is still in progress from a finding that remains open after reporting. The scope is the anchor for deciding which requirement was examined; the finding explains the observed gap.

Audits move through planned, in progress, reporting and closed states. Findings use observation, minor and major severity choices. An Auditor can prepare a reporting review with the underlying finding records visible, and the Quality Reviewer can examine due dates and closure dates across audits. A completed audit does not by itself tell the team whether all findings have been resolved, so review both records during the handoff.

How the work is organized

  • Planning. Define scope, a planned date and a named Auditor for each audit.
  • Evidence. Record each requirement and finding under the correct audit with severity and owner.
  • Follow-up. Use due and closure dates to see which finding still needs attention.

What to agree during setup

Agree the audit-number convention and the level of detail expected in a scope. Decide how auditors cite a requirement and what evidence is kept with the finding text. Name the People records that may act as Auditor and finding Owner. Set a consistent practice for severity classification: an observation should remain distinguishable from minor or major findings. Decide who checks a finding before its closure date is entered and how the team reconciles open findings with an audit marked closed.

The app keeps audit findings and their owners. If a finding requires correction under a linked inspection issue, coordinate that work explicitly through the quality records. A finding’s due date is a tracking point; it is not proof that the corrective work has passed effectiveness review.

Check the handoff on an actual case

Create an audit with a defined production area scope, planned date and Auditor. Record a requirement and a major finding, assign a People owner and set a due date. Move the audit through reporting and have the Auditor compare its finding list with the report. Ask the Quality Reviewer to open the due-findings screen, identify the owner and inspect the closure date. Rehearse a finding that remains open while the audit itself reaches closed status, so the follow-up does not disappear from the team’s queue.

Also check an observation with no immediate corrective work. It should still retain its requirement and audit link for later reference. The two findings should remain distinct records rather than being folded into a broad audit status.

What your team sees

  • Audit findings due — Requirements and findings with owners, severity and dates for follow-up.
  • Training acknowledgment history — Document acknowledgments that may be relevant to an audit review.

Follow the work through

Use audit and finding review to rehearse scope, finding ownership and closure follow-up.

What it keeps track of

Data model
Audits
Audits records for Quality & Compliance (Source).
Audit findings
Audit Findings records for Quality & Compliance (Source).
People
People records for Quality & Compliance (Source).
Controlled documents
Controlled Documents records for Quality & Compliance (Source).
Training acknowledgments
Training Acknowledgments records for Quality & Compliance (Source).

Who uses it

Permissions
Auditor
Plans and conducts the audit.
Quality Reviewer
Follows findings across the quality operation.
Document Controller
Helps locate controlled versions and acknowledgments when they are relevant.

Set up Pharmaceuticals QMS your way.

Start free, then use Proto to change fields, steps and approvals before your team goes live.

How to get started