We generally use a pragmatic way to create and maintain the documentation and the process needed for Computerized Systems Validation, such as:

    risk analysis
    user requirements
    validation plan
    functional specifications
    test plan
    test cases
    test logs
    validation report
    supplier audits

We assist you in:

    Documenting, planning and performing Computerized Systems Validation
    Maintaining your system in a validated state
    Implementing 21 CFR Part 11 (Electronic Records & Electronic Signatures)
    Auditing your systems and your suppliers
    Proactive system maintenance
    data integrity investigation

We have expertise in Electronic Document Management and in handling of electronic records. According to our experience there is a high probability, Authorities will ask in future inspections for your procedures concerning electronic records and therefore a good preparation for these questions with our expertise is essential for the success of your company.