Validation – applies to a process; ensures proper operation with safeguards against improper processing; verifies software and qualified hardware are suitable to do a process that may include many tasks
Validation is…
- The establishment of documented evidence that a system or process does what it is intended to do
- It encompasses verification. Validation asks “Are we building the right system?” and verification asks “Is the system being built right?”
- Qualify equipments vs. Validate processes
Users of the computer system are responsible for validation
- Is performed on the same environment as the production (hardware, software, OS, data)
- Is performed before production use or before changes are made in production system
- It addresses System requirements and installation, Training, Risk assessment, operational verification, controlled corrective actions…
Standard Validation
Validation is one of the most significant pre-requisites for a pharmacovigilance system. Validation would ensure that the functionality is working as per the standard
Standard validation would include:
- Validation documents would be available as per the Sarjen system’s templates
- Validations documents set out in the contract agreement will be delivered
Customized Validation
Customized validation would include:
- Customized validation as per client’s requirements
- Validations documents as per client’s template
- Validation documents as set out mutually in the agreement