A quality review tool for pharma teams who want inspection-ready evidence
Regulatory inspections are lost on small things: a line clearance that was not signed, a backdated record, a CAPA that was opened and never checked. AuditFlow helps QA teams run GMP walk-throughs, batch record reviews and data integrity audits on one system, with evidence that carries its own time and place.
What it covers, and what it does not
AuditFlow covers the audit and review side of pharma quality: walk-throughs, record reviews, data integrity checks, deviations and CAPA follow-up. Templates are mapped to GMP and Schedule M, with ISO 13485 and 21 CFR Part 11 references where relevant.
It is not a statistical trending tool for an Annual Product Quality Review (APQR) and it does not replace your LIMS or QMS. Teams use it to collect the review evidence that feeds those processes.
Pharma templates in the catalogue
- GMP area walk-through: line clearance, materials for the current batch only, status labels, gowning for the area grade, differential pressure
- Data integrity (ALCOA+) audit
- Batch manufacturing record review
- Cleaning validation verification
Why QA teams move off paper and Excel
No backdating
Each answer and photo is time-stamped when it is captured, and plausibility flags show timestamp or location mismatches for a reviewer.
Every deviation has an owner
A failed check opens a corrective action with an owner and due date, so effectiveness checks are tracked.
One evidence pack
The completed audit compiles into a PDF report you can hand to a visiting inspector or certification body.
Works on the shop floor
Audits run offline in clean rooms and warehouses with weak signal, then sync.
Questions people ask
Is AuditFlow an APQR software?
No. It does not calculate product quality trends. It is used for the audits and record reviews that feed your quality review, and for tracking the corrective actions that come out of it.
Which frameworks are mapped?
The pharma templates reference GMP and Schedule M, with ISO 13485, ISO 9001 and 21 CFR Part 11 where they apply. You can add your own SOP references.
Is it suitable for CDMOs and medical device makers?
Yes. The pharma catalogue is written for drug manufacturers, CDMOs, medical device makers, clinical labs and API producers.
Can we try it before buying?
Yes. You can run a template free in the app before choosing a plan.