Audit of the QA Programme
Providing assurance the QA programme meets the regulatory requirements
The MHRA GLP monitoring authority guidance requires the Quality Assurance Programme to be audited to “…determine the extent to which the QA programme meets the requirements of GLP and to which it complies with the requirements of the test facility’s own processes and procedures”.
OECD GLP Document No. 23 also refers to a verification of the QA programme and its effectiveness. It suggests an audit of QA activities is performed.
The Knowlogy has performed independent audits of the QA programme and QA activities in the UK, Europe, USA and Asia against local GLP regulations and the OECD guidance on QA and GLP. We have also performed audits of the QA programme and activities for GCP laboratories.
Audit of QA
Audit Level Options
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£1,235 + VAT
For small organisations with a basic audit programme (facility, study audits)
Whats Included
- Pre-audit planning call (30 minutes)
- Audit Plan
- ½ day remote audit
- Audit Report: list of documents reviewed and non-compliance
- Audit certificate
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£2,015 + VAT
For organisations with risk based audit programme and QA has additional roles such as document controller, archivist
Whats Included
- Pre-audit planning call (30 minutes)
- Audit Plan
- 1 day remote audit
- Audit Report: list of documents reviewed and non-compliance
- Follow-up on responses to non-compliance
- Audit certificate
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£2,535 + VAT & Travel
As for Complaince Standard with additional insights on process improvements, industry practice, regulatory expectations. Ideal for providing development to QA team.
Whats Included
- Pre-audit planning call (30minutes)
- Audit Plan
- 1 day on-site audit
- Audit Report: list of documents reviewed, non-compliance and recommendations
- Follow-up on responses to non-compliance
- Audit certificate