Vendor Audits
When you are outsourcing your pre-clinical studies and clinical trials, you need assurance of regulatory compliance. The Knowlogy will deliver qualification and re-qualification audits to provide this assurance
Why you need a vendor audit.
Sponsors are responsible for ensuring that any vendor performing pre-clinical studies or activities in a clinical trial complies with applicable regulations and guidance documents.
Assurance can be provided to Sponsors by performing pre-qualification and re-qualification audits conducted by Quality Assurance professionals.
The Knowlogy provides vendor auditing services and has experience auditing across the globe, both remotely and on-site.
Our areas of expertise.
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Phase I Unit
Pharmacy
Data Management
Laboratory
Archiving
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Central Labs
Safety Labs
Method Validation (ICH, FDA)
PK/PD Bioanalytical
Biomarkers
Immunoassay
Flow Cytometry
PCR
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Pre-clinical
Toxicology
Pharmacology
Bioanalytical
Flow Cytometry
PCR
Biomarkers
Method Validation
Histopathology
Statistics
Archives
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Computer system validation
Change control
LIMS
Laboratory systems
Electronic Quality Management Systems
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CAP/CLIA
ISO 9001
ISO 17025
ISO 15189
ISO 10993
Our Process
When we receive an initial enquiry for a vendor audit. We will confirm requirements, timeline expectations and if The Knowlogy SOPs or Client SOPs are to be followed.
A quote will be provided for approval.
Audit Request & Agreement
During the preparation phase, a pre-audit call with applicable personnel is held to confirm the audit objectives, criteria, scope and areas of concern or focus points.
An audit plan, agenda, and document request list are prepared for client review before being shared with the auditee.
During this time, contact with the auditee to arrange dates and logistics will be made.
Audit Planning
The conduct of the audit.
If critical observation or key objectives of the audit cannot be met the client will be informed immediately.
A summary of observations will be provided within 24hours of audit completion.
Audit Execution
An audit report will be provided within 10 working days.
The Knowlogy will provide either
Summary Report
Executive summary
List of documents and records reviewed
Non-compliances
Full Report
Executive summary
List of documents and records reviewed
Non-compliances
Description of the organisation and key processes
An Audit Certificate is provided for all audits.
Audit Reporting
Audit Follow-up
If required The Knowlogy can follow-up any reponses to actionable non-conformances by the Vendor.