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
AUDITING
The Knowlogy can provide experienced auditing resource to your existing audit team enabling you to meet your clients deadlines
AUDIT MANAGEMENT
The Knowlogy can provide Quality Assurance function if your organisation cannot justify appointing a dedicated full-time QA.
VENDOR & SYSTEMS AUDITS
The Knowlogy can provide audits of contract research organisations (CROs) and service providers on your behalf
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