Audit of the QA Programme

As test facility management, it is your responsibility to ensure that the principles of GLP are complied with in the test facility. This includes the QA programme.

We will conduct an independent audit of your Quality Assurance programme, and any activities they undertakes to provide assurance you are meeting the regulatory requirements.

Submit a request

Why you need a QA Audit.

Did you know that in the UK 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”.

For the rest of the world the OECD GLP Document No. 23 also refers to a verification of the QA programme and its effectiveness which can be met by an audit of QA activities.

The Knowlogy have been conducting independent audits of Quality Assurance for 10 years across the UK, Europe, USA and Asia.

We are qualified to deliver audits for both GLP facilities and GCP laboratories.

QA Audit Level Options

  • Compliance simple

    £1,105 + VAT

    For organisations that perform <5 studies per year , QA is not full time, or QA only has responsibiity for the QA programme

    Whats Included

    ✔️ Introductory call to set ways of working together (30minutes);

    ✔️ Audit Plan; provided to confirm the criteria and scope (boundaries)

    ✔️ Remote ½ day audit

    ✔️ Audit Report: list of documents reviewed, non-compliance

    ✔️ Audit certificate

    Submit a request
  • COMPLIANCE - Standard

    £1,625 + VAT

    For organisations with a risk-based audit programme and QA is involved in additional activities, i.e. CAPA, deviations

    Whats Included

    ✔️ Introductory call to set ways of working together (30minutes);

    ✔️ Audit Plan; provided to confirm the criteria and scope (boundaries)

    ✔️ Remote 1 day audit

    ✔️ Audit Report: list of documents reviewed, non-compliance

    ✔️ Audit certificate

    Submit a request
  • COMPLIANCE + Process Excellence

    £2,015 + VAT

    For organisations that need the Compliance standard audit and also require on-site training for your internal QA

    Whats Included

    ✔️ Introductory call to set ways of working together (30minutes);

    ✔️ Audit Plan; provided to confirm the criteria and scope (boundaries)

    ✔️ On-site 1-day audit and training

    ✔️ Audit Report: list of documents reviewed, non-compliance

    ✔️ Recommendations on process improvement

    ✔️ Feedback on planned actions to any non-compliance

    ✔️ Audit certificate

    Submit a request