Audits

Tower Mains has the capability to support your entire regulatory audit programme from early development to post-market surveillance; whether it be a single audit or global programme of audits.

Examples of some of our audit experience;

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
  • Investigator Site Audits

  • Sponsor system / Process audits

  • Document audits

    • Data & Report audits
    • Electronic Trial Master File (eTMF)
    • Clinical Study Plan audits
    • Inspection dossier
  • Marketing Authorisation Applications and Common Technical Documents

Good Laboratory Practice (GLP)

  • Vendor Audit

    • Contract Research Organisation
    • Pre-clinical facilities
    • Contract laboratories
    • Histopathology facilities
    • Archives
  • Method Validation Audit Test Facility/Sites

    • Facility Audits
    • Process 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

    • System Audits of Sponsor/CRO Operations
  • Vendor Audits

    • CROs
    • Phase I units
    • Monitoring & Project Management
    • Data Management, Biostatistics and 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 study plans including management, risk management and monitoring plans

GCP for Laboratories

  • Vendor Audits

    • Central Laboratories
    • Biomarkers
    • Immunoassay
    • Bioanalytical
  • Method Validation Audit
  • Study Audits

    • Analytical plans/amendments
    • Critical phase
    • Raw data
    • Final report
  • Computer System Validation Audit

Good Manufacturing Practice (GMP)/Good Distribution Practice (GDP)

  • Vendor Audit

    • API & IMP manufacture
    • Storage & distribution centres
    • Test laboratories
    • Contract management organisations
  • Marketing Authorisation Applications / Common Technical Documents

Medical Device

  • Supplier qualification audits
  • Regulation audit
  • Biocompatibility testing audits

Discuss Your Audit Requirements