QMSdesk

PlatformAudit management

Audit management software with independence built in

QMSdesk™ audit management software runs your audit program from plan to closure. Findings enter your quality system the moment they're raised, and you can host an inspector with confidence.

What changes for your team

01

Every finding in one place

One register lists every finding across every audit you can see. "Show me every open finding" has one answer, in one place.

02

Serious findings act on their own

A critical finding raises a nonconformance and a risk automatically. A major finding raises a nonconformance. Neither can sit quietly in a report.

03

Hosting an inspector, calmly

Give an inspector a time-boxed, read-only account that can see and export records but cannot change or sign anything. Every record they open is logged.

GMP audit software, from plan to closed

Your annual internal audit of the warehouse is on the calendar. Here is how it runs.

  1. Step 1 of 6

    Planned

    The audit is set up from your program, calendar and templates.

  2. Step 2 of 6

    Scheduled

    A lead auditor and team are assigned. QMSdesk won't let anyone audit their own department.

  3. Step 3 of 6

    In progress

    The team works through the checklist, collects evidence and records findings.

  4. Step 4 of 6

    Completed

    The lead auditor signs, attesting what was found.

  5. Step 5 of 6

    Approved

    Management signs the report. The lead auditor can't approve their own.

  6. Step 6 of 6

    Closed

    The audit record is complete, linked and permanent.

Opportunities for improvement and positive observations go in the report too. They don't create findings, owners or deadlines, so your auditors can record good practice freely. A step that runs late escalates, so no audit stalls unnoticed.

Audit management software highlights

Inspection View

Inspection View gives an inspector or a customer auditor a dedicated, time-boxed, read-only account that can see and export records but cannot change or sign anything. The controls that create, edit or sign never appear. Export and download stay available, so evidence is never harder to reach. The account stops working when its time is up, and every access is logged. An Inspection View account is an account you create for your inspector, and it needs a login like any other.

An audit findings register across every audit

Each finding lives in the audit that raised it, and one register lists them across all the audits you can see. Follow up on every open finding without opening each audit in turn.

Independence enforced when it counts

Auditors can't audit their own department, and the lead auditor can't approve their own report. QMSdesk enforces both, so independence never depends on someone remembering.

Findings that join the closed loop

Critical findings raise a nonconformance and a risk, and major findings raise a nonconformance, automatically and always. You can also switch on automatic CAPA for each audit type. When you do, the CAPA links to the nonconformance, so one finding leads to one connected chain.

Feature index

Everything in audit management

Program and planning

  • Audit program, calendar and templates
  • Auditor qualification profiles
  • Internal, supplier and external audits

Lifecycle and signatures

  • Lifecycle: Planned, Scheduled, In progress, Completed, Approved, Closed
  • Completion signed by the lead auditor, approval signed by management
  • Auditors never audit their own department
  • The lead auditor never approves their own report
  • Step deadlines with escalation

Findings

  • Finding severities from observation to critical
  • Critical findings raise a nonconformance and a risk automatically
  • Major findings raise a nonconformance automatically
  • Optional automatic CAPA per audit type, linked to the nonconformance
  • Opportunities for improvement and positive observations, recorded without finding consequences
  • A findings register across all audits

Inspection View

  • Dedicated, time-boxed, read-only inspector accounts
  • Create, edit and sign controls withheld
  • Export and download kept available
  • Account expiry enforced at sign-in
  • Every access logged

Records

One connected system

Connected across QMSdesk

Deviation and nonconformance management receives the nonconformances your findings raise.

Risk management receives the risk a critical finding raises.

CAPA can start from an audit, with or without an event.

Supplier quality relies on your supplier audits.

Regulations

Regulations it's designed to support

  • ISO 13485. QMSdesk is built to support organizations working to ISO 13485:2016, including internal audit (§8.2.4).
  • FDA QMSR. FDA now inspects under compliance program 7382.850, and an ISO 13485 certificate does not exempt a site from inspection.
  • 21 CFR Part 58 (GLP). Under the GLP profile, a five-step QAU finding workflow notifies management within 7 days.
  • 21 CFR Part 11. Audit signatures use controls for Part 11 electronic signatures.

Questions buyers ask

Can we give an FDA inspector access to our records?

Yes, through Inspection View: a time-boxed, read-only account that can see and export records but cannot change or sign anything. You create the account, it expires on the date you set, and every access is logged.

What happens when an auditor raises a critical finding?

QMSdesk raises a nonconformance and a risk automatically. A major finding raises a nonconformance. You can also turn on automatic CAPA for each audit type, linked to that nonconformance.

How is auditor independence enforced?

Auditors can't audit their own department, and the lead auditor can't approve their own report. Completion and approval are separate signatures by different people.

Can we see every open finding across all our audits?

Yes. The findings register lists findings across every audit you can see, in one place.

Do opportunities for improvement create CAPAs?

No. Opportunities for improvement and positive observations are recorded in the report without an owner, a deadline or any follow-on record.

Audits that close the loop

Bring your last audit report. We'll show you QMSdesk turning its findings into owned, linked work.