Audits
Tower Mains has the capability to support your entire regulatory audit programme from early development to manufacturing, whether it be as your internal Quality Assurance Unit managing and performing your internal audit programme, or on an as needed basis for a single audit or global programme of audits.
Examples of some of our audit experience:
Good Laboratory Practice (GLP)
Vendor Audit
- Contract Research Organisations
- Pre-clinical Facilities
- Contract Laboratories
- Histopathology Facilities
- Statistical Facilities
- Archives
Test Facility/Sites
- Facility Audits
- Process Audits
- System Audits
Study Audit
- Study plan/Amendments
- Critical Phase
- Raw Data
- Final Report
Computer System Validation Audits
Good Clinical Practice (GCP)
Investigator Site Audits
- Routine / Targeted / For Cause Investigator Site Audits (Phase I to IV)
System Audits
- Internal
- Third Party Activities
Vendor Audits
- CROs
- Phase I Units
- Monitoring & Project Management
- Data Management, Biostatistics & Medical Writing
- Clinical Trial Supply
- Archive Facility
- Imaging Facilities
- Statistics
Computer System Validation Audit
Data Management Audits
- Database
- Data Management System
Trial Master File (TMF) Audits
- Trial Master File Audit (paper and electronic)
Document Audits
- Protocol
- Case Report Forms
- Informed Consent Forms
- Investigator’s Brochures
- Clinical Study Reports
- Development Safety Update Reports
- Clinical Plans including Management, Risk Management & Monitoring Plans
GCP for Laboratories
Vendor Audits
- Central Laboratories
- Biomarkers
- Immunoassay
- Bioanalytical
Computer System Validation Audit
Study Audits
- Plans / Amendments
- Critical Phase
- Raw Data
- Final Report
Good Manufacturing Practice (GMP)/Good Distribution Practice (GDP)
Vendor Audits from Development to Commercial
- Manufacturing
- Storage & Distribution Centres
- Test Laboratories
Marketing Authorisation Applications / Common Technical Documents Submissions
Medical Device
Supplier Qualification Audits
Regulation Gap Assessment
Biocompatibility Testing Audits
Remote Audits
Tower Mains have conducted remote audits since 2012 against the GLP, GCP and GMP regulations. Example of audits conducted include:
Electronic System Vendor Audits
Computer System Validation Audits
Data and Report Audits
Vendor Qualification Audits
- Contract Laboratories
- Phase I Units
- Pre-clinical CRO
Sponsor System / Process Audits
Document Audits
- Data & Report Audits
- Electronic Trial Master File (eTMF)
- Clinical Study Plan Audits
- Inspection Dossier
Investigator Site Audits
Testimonials
“Andrew exemplifies what a professional and responsible auditor is and is definitely teaching Tower Mains auditors in the responsible way.”