Your supplier has probably already been audited
6,000+ completed GxP audits. 150+ added every month. Search the site you're qualifying and find out whether the report already exists, before you budget the trip.
Three ways to get the audit report
Most people find the report already exists. The rest have two faster options than flying someone out.
The report already exists
Audited, written, finished. You request it and it's yours. No date to agree, no travel to fund. Most common for API and finished dose sites in India, China and Europe.
Search the library arrow_forwardThe audit is already scheduled
The site is already on our audit calendar. Join before the auditor goes and you get the report without sourcing an auditor, agreeing a date or sending anyone.
See planned audits arrow_forwardAn audit built around your scope
Tell us the site and the scope you need. We schedule it within four weeks with an auditor based in that country, and the report is yours.
Request a new audit arrow_forward
Sixty seconds to find out
Search the supplier name
Type the site or company name and see what is already on file.
Or filter by country and category
Narrow to what you are qualifying: API, finished dose, packaging, excipients, distribution or laboratories.
Check the standard and the date
Every entry shows the audit standard, country, site location and audit date, so one look tells you whether it fits your file.
Try it right here
Search a supplier and open the result to see it in the full Audit Library.
Audit Library
Request a completed report, join an audit already scheduled, or have a new one arranged.
For this supplier there is no audit report available or has been scheduled yet. We are happy to organize a new audit for you.
Request a new auditAudit standards
Every audit is run against the standard that applies to the supplier you are qualifying.
API (Active Pharmaceutical Ingredients) / Drug substances
ICH Q7, EU GMP Part II
FDF (Finished Dosage Forms) / Drug products
EU GMP Part I (including its Annexes when necessary)
Excipients
IPEC, PQG Joint GMP Guide for Pharmaceutical Excipients
Packaging materials
Primary and secondary
ISO 15378 | ISO 9001
Applicable parts of the EU GMP Part I when necessary
Transport and/or distribution
Raw materials and FDF
EU GDP (2015/C/95/01) and/or EU GDP (2013/C/343/01)
Subcontracted laboratories
Physicochemical testing | Microbiological testing | Bioanalytical testing | Stabilities | ...
Applicable GxP guidances
Clinical trials
Investigational sites | Vendors/Suppliers | Laboratories
ICH GCP and applicable GxP guidances when necessary
Pharmacovigilance
Services | Vendors
EMA GVP and applicable GxP guidances when necessary
Medical devices
EU MDR (GMP) | ISO 13485
Software vendors
GAMP 5
Cosmetics
ISO 22716
Food
IFS/BRC | FSSC/ISO
ESG
GRI Sustainability Reporting Standards
Other vendors
ISO 9001
Bespoke audits
Internal audits | Mock inspections | Gap analysis
Upon agreement
How every audit is run
Full transparency at every stage, not a generic checklist
Full transparency
Our pre-audit team confirms dates and selects the most suitable auditor or team.
Preparation tailored to the site
Built around the supplier's processes and your requirements, not a template.
Every report reviewed internally
An internal review ensures every report is consistent, substantiated and fit for purpose.
Drafts shared before issuance
You and the supplier comment on the draft before the report is issued, so nothing lands as a surprise.
CAPAs followed to closure
Actions reviewed for adequacy, CAPAs tracked, with status updates until closure.
Auditor qualification
Every auditor qualified before they audit for you
Auditors live in the regions they audit and work in the local language and regulatory context. Six steps before an auditor sets foot on a site on your behalf.
Continuous auditor monitoring
Step 6 never ends. Every auditor is reviewed against four measures.
- checkTimely delivery of draft reports
- checkConsistency with our reporting standard
- checkExternal feedback from customers and auditees
- checkFormal performance reviews and twice-yearly regulatory updates
Same evidence. Very different invoice.
Arranging the audit yourself
With the Qualifyze Audit Library
Trusted by industry leaders
We have valued our experience working with Qualifyze on audit reports because of their reliable customer service, collaboration and thoroughness.
“We chose to collaborate with Qualifyze, not only for their extensive audit database and fast delivery times but also for the precision and high quality of their reports.”
“Qualifyze helped us reduce costs and time thanks to their team of experienced auditors.”
Quality teams working with us
Check the library before you book the flight
Search one supplier now, or take the complete list of audited sites and run it against your own approved supplier list.
Download the full audit list
We send the complete list of audited sites as a file. Run it against your approved supplier list and see what is already covered.