Validation of computerized systems regulated by Application 11 GxP EU Manual for pharmaceutical industry. The concept of a computerized system includes: computer hardware, software, peripheral devices, networking system, documentation, and staff, which interact with hardware and software. Besides of documented proof of the system compliance by certain requirements, validation covers whole life cycle of a computerized system – starting with design and ending with decommissioning.
Validation Documents include:
- User Requirements Specification (URS)
- Project
- Functional Specification (FS)
- Technical Specification (TS)
- Configuration Specification (CS)
- SOP manuals for Maintenance and Operating
Availability of the actual project, URS & FS are components for successful pass of the first stage of validation – project qualification (DQ). On a stage of montage qualification (IQ) it’s required to check equipment package, proper installation, package and actuality obtained documents, correspond of using device base in TS, correspond view and correctness device name. On a stage of functioning qualification (ОQ) it’s required to check trained staff, SOP documents, correctness system function fulfill and related equipment. In this case, all conditions of the test must be approached to conditions of real system operation. On a stage of working qualification (РQ) it’s required to check correctness system operation by determined requirements.
Computerized systems of TERA company fully correspond by validated requirements. TERA company also provides with validation services for its customers, which fulfilled by TERA’s staff cooperating with leading expert in validation.
