Audits of vendors is a critical activity that must be undertaken by sponsor companies. A vendor audit is essentially a mechanism to inspect and evaluate a vendor’s quality practices, products and documentation to ensure they meet the standards required for development/conduct of regulated activities. Conduct of vendor audits is not just a regulatory requirement, it makes good business sense.
The sooner vendors are audited, the better. An audit will identify gaps in vendor’s quality processes that should be addressed. Addressing these gaps at the earliest opportunity drives better quality and compliance and reduces the risk of issues becoming major quality events that potentially could derail a program. DArcy Compliance Consulting has undertaken GCP and GMP vendor audits for many of our clients. See a case study in Vendor Audits.