Regulatory authorities specify that “the sponsor is ultimately responsible for the validation of the computerised system and for providing adequate documented evidence on the validation process.” Put simply, a sponsor is required to ensure that there is sufficient evidence proving that the platform or system used for clinical trial data collection and management is fit for the intended purpose. These validation requirements help ensure that the regulatory authorities will regard all the data collected by the system as “reliable” and not “unreliable,” which would have a devastating impact on any clinical trial.
CSV (Computer System Validation) can, however, be a complex task. We often hear customers say: “I simply don’t have the resources available, on demand, to do this CSV, particularly for a system, which, quite frankly, shouldn’t be on the market if it doesn’t already comply with regulatory requirements.” As industry veterans, Bioforum understands this frustration. The costs and effort associated with CSV can be significant.
The good news is that CSV is easily manageable, if approached systematically. The first step is for sponsors to outline their own specific use case, identifying the requirements a technology system or platform must meet to ensure compliance. It’s also a mistake to assume that any supporting CSV documentation provided by a technology vendor cannot be used as evidence. Vendors are aware of and very familiar with most intended use cases, so they generally are well prepared to provide supporting documentation when needed.
What success comes down to is how thoughtfully and accurately requirements, processes and, of course, evidence of subsequent testing are documented. While this documentation can be overwhelming, sponsors don’t have to go it alone. They can outsource CSV support to CROs, QA vendors and other experienced service providers. In addition to addressing resourcing concerns, CSV-related outsourcing can also provide the needed confidence and expertise to ensure regulatory compliance.