Audit with The Knowlogy

AUDIT TRANSFORMED

Our belief is audit should be of mutual benefit to the audit client (who requires the audit) and the auditee (who is being audited). We will work with all interested parties to achieve excellence in generating quality data with our collaborative approach. How do you benefit from working with The Knowlogy;

Collaborative

Work with the audit client and auditee

Beneficial

Independent assessment of processes & quality system

Scope

Defined scope agreed by all parties

Criteria

Audit criteria defined and agreed

Educational

Gain knowledge & experience through audit

Tailored

To what the audit is to achieve

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AUDITING

The Knowlogy can provide experienced auditing resource to your existing audit team enabling you to meet your clients deadlines

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AUDIT MANAGEMENT

The Knowlogy can provide Quality Assurance function if your organisation cannot justify appointing a dedicated full-time QA.

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VENDOR & SYSTEMS AUDITS

The Knowlogy can provide audits of contract research organisations (CROs) and service providers on your behalf

The-Knowlogy

Our aim is to provide all scientists with convenient access to knowledge

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Regulations and Standards

The Knowlogy’s Auditing expertise, on-site and remote encompasses;
  • Good Laboratory Practice(GLP)

Vendor Audit

  • Contract Research Organisation
  • Pre-clinical facilities
  • Contract laboratories
  • Histopathology facilities
  • Archives
  • Biocompatibility testing studies (ISO 10993)

Study Audits

  • Study Plan/amendments
  • Critical phase
  • Raw data
  • Final report

OECD and FDA 21 CFR 58 in countries; UK, USA, France, Belgium, Netherlands, Germany, Italy, Singapore, Australia 
For Pharma, Chemicals, Biocidals, Agrochemicals, Medical Devices

  • Good Clinical Practice for Laboratories

Vendor Audit

  • Central Laboratories
  • Biomarkers
  • Immunoassay
  • Bioanalytical
  • Method validation

Study Audits

  • Analytical Plan/amendments
  • Critical phase
  • Raw data
  • Final report

ICH GCP E6, EMA Reflection paper (EMA/INS/GCP/532137/2010) and WHO Good Clinical Laboratory Practice in countries; UK, USA, France, Belgium, Netherlands, Germany, Japan, Australia

  • Good Research Practice (exploratory studies not regulated)
  • Computer Systems Validation
  • Analytical Systems
  • Laboratory Information Systems
  • Electronic Laboratory Notebooks
  • Cloud Based Systems
  • Quality Management Systems
  • Document Management Systems
  • Electronic Signatures