Prudentia produces validated computer system solutions. We do it for our systems and we do it for our clients’ systems. Our team of onshore and offshore resources can lead validation streams, author test scripts, dry run scripts, pre-approve scripts, execute scripts, and post-approve scripts.

Our team can also author validation plans, data migration plans, risk assessments, trace matrices, test plans, test summary reports, and validation summary reports. Our team is well versed in GAMP 5 processes supporting FDA CFR 21 Part 11 and EU Annex 11.