QA-Services specialized

Specialised Service Providers/Supplier/Vendors Audits

  • We can perform Software Supplier and Service Provider Qualification Audits to support organisations to make their best choice for their regulated activities. E.g. for:

    • Electronic Case Report Forms (eCRFs)
    • Electronical Clinical Outcome Assessment (eCOA), e.g. electronical Patient Reporting Outcome (ePRO)
    • Electronic Electro Cardiogram (eECG)
    • Lung Function
    • Imaging
    • Electronic TMFs (eTMFs)
    • Safety Database
    • Clinical Trial Management System (CTMS)
    • Data Centre
    • IT Operations
    • Software Development

Validation status audits of single computerised systems and/or environments

  • We can perform Validation Audits within organisations with the focus on the in house validation of purchased software solutions and their study specific setup (e.g. eCRF, eTMF; CTMS; Safety Databases)