Why Computer System Validation?
It is a necessity in the pharma industry to ensure adherence to pharmaceutical cGMP
guidelines, and to help companies maintain consistent quality. The same principles should
apply in computer system validation to a computer system or an information technology
system. Computer system validation checks the effectiveness and the efficiency of product
and meeting the requirement for which it designed.
Processes Needed for Computer System Validation
CSV is dependent on the complexity of the project and can be largely broken down into the
It checks whether the specifications are in line with user requirements and teams are also
established which will run the entire process. The set of activities need to be carry during
validation will established and this is the process of preparing the blueprint for the
entire CSV. This process is the pivot of a validation program since it covers the complete
It defines the standard operating procedures for each process in a validation assessment
program and is a subset of the master validation plan. Mainly, it defines a deadline within
which the CSV must complete. A detailed documentation and training on the standard operating
procedures (SOPs) carried out in this process.
Installation Qualification (IQ)
IQ delves deeper into the installation process, creates checks, and balances for any new
component that may have been require or any new software or hardware that might have
Operational Qualification (OQ)
OQ checks the accuracy of the operational functions and the security process such as physical
security, software security, firewalls etc.
Performance/Process Qualification (PQ)
PQ tests specific applications and proactively engages in maintenance and conducts
Computer System Validation expert have validated computer programs including pharmaceutical
and biologics manufacturers and clinical research organizations.
Computer systems validation services for SAP, LIMS, Salesforce, and data management system.