Computerized systems validation

Computer system validation (CSV) is the documented process of assuring that a computer system does exactly what it is designed to do in a consistent and reproducible manner. The validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules.

The business and operational processes of clinical trials have been slow to catch up with emerging technology and it’s imperative for pharma and contract research organizations to adapt these changing technologies for business transformation in this today’s digital age. Embracing technologies often brings its own set of complexities, often exacerbated by strict regulations in clinical trials and drug development, and new tools and technology need to meet all regulatory mandates before using for clinical trials.

A process critical step in using technology platforms in clinical trials is the computer system validation of these tools to ascertain the functionalities and applications of the systems are on par with the mandate and requirement standards. There are three important areas that these technologies need validation for – regulation, technology and security.

It is important that these computer systems comply to the most recent regulatory standards when it comes to implementing them in clinical trials. Both USFDA (United Stated Food and Drug Administration) and EMA (European Medicines Agency) have very robust requirements for systems operations and privacy of patient data. It is important for the vendors of these systems to be aware and understand the most current regulatory requirements when it comes to computer systems validation.

The platforms used in clinical trials settings contain critical patient information. These systems keep exchanging patient data continuously over the internet and need to be protected. GAMP (Good Automated Manufacturing Practice) principles outline the requirements for patient safety, records and data integrity while employing computer systems validation which plays a key role in the overall integrity of data and the systems. It is critical to validate the consistency of these systems and understand the security of patient data. It is important to secure patient data via encryption at different point of times. Validation teams involved in sprints, testing, validation, deployment should have an in-depth understanding of these eSystems and its application in clinical trials to recognize the overall criticality of the process.

Computer system validation is a mission critical process in harnessing the power of technology in clinical trials and drug development, and should be conducted in a robust manner by appropriate stakeholders and host the right team for such critical and sensitive activity.