Independent CDMO, CRO and GxP vendor audits
Supplier qualification and GxP system vendor audits, with findings, CAPA follow up and risk based oversight.
CDMO and CMO qualification audits
Supplier qualification audits of CDMOs, CMOs and service providers.
CRO audits and sponsor oversight under ICH E6(R3)
Audits that give sponsors evidence of CRO oversight. See eTMF inspection readiness.
Software and SaaS vendor audits
Audits of GxP system and SaaS vendors with a risk rated report.
Remote or on site
Remote audits are preferred. On site audits bill travel at cost, with no markup.
Findings, CAPA and ongoing oversight
Risk rated findings, CAPA review and ongoing risk based oversight.
Prices
| Package | Scope and deliverables | Timeline | Flat price |
|---|---|---|---|
| Remote Vendor Audit | GxP system or SaaS vendor: plan, remote audit, risk rated report, CAPA review | 2 to 3 weeks | $3,500 |
| On site Vendor Audit (1 day) | CRO, CMO or service provider; travel at cost | 3 to 4 weeks | $5,000 |
| Audit Bundle (3 remote) | Three remote vendor audits in a year | Annual | $9,500 |
Each package lists what is out of scope. Anything beyond bills at the rate card or converts to a change order at a pre stated price.
FAQ
- How do you audit a CDMO?
- We audit against your quality agreement and GMP obligations, then rank findings by risk and give a CAPA follow up plan.
- Do you audit software vendors?
- Yes, including Part 11, data integrity and the vendor's development and testing controls.
- Can audits be remote?
- Yes. Remote audits are preferred; on site audits are available with travel billed at cost.
- What do we receive?
- An audit report with classified findings and a recommended follow up plan.