Validation

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.