Computer System Validation (CSV) is a core area of expertise offered by Skillpad's Compliance Consultants. Skillpad understands it is vital that all computer hardware and software systems function according to design.
CSV ensures that off-the-shelf or custom-built systems comply with regulatory requirements and can be relied upon to produce results that are consistent and reproducible.
In addition, the data collected and recorded by computerized systems must meet the highest standards of integrity. Depending on the complexity of the system and organizational demands, this can be extremely challenging.
Skillpad's Compliance Consultants have extensive experience in CSV following GAMP5 principles. We work closely with our clients to develop and execute CSV solutions that are efficient and effective.