Qualification and Validation of Facilities, Equipment’s And Utilities
Qualification and validation support
We provide complete support for qualification and validation of facility, equipments, utilities like water system, AHU’s compressed air and nitrogen (if necessary).
This includes preparation execution of the following:
- URS (user requirement specification) through Risk Assessment
- Design qualification and design reviews
- Factory acceptance tests ( would be done at the equipment manufacturer’s premises)
- SAT (Site Acceptance Test) / Commissioning
- Installation qualification
- Operation qualification
- Performance qualification
- Process validation and cleaning validation also would be executed as per Regulatory/clients requirements.
Upon installation of equipments and utilities by representatives of OEMs, we provide commissioning support by our team during this stage.
Designing of New Facilities:
- Feasibility Studies & Master Planning
- Conceptual Design Studies
- Basic Engineering
- Detailed Engineering
- Project Management
- Procurement Assistance
- Construction Management
- Commissioning Support
- Qualification and Validation
- Automation requirements and software validation
Assessment of automation required in the facility which will include vacuum transfer systems, PLC requirements, automatic cartoning and etc.
We will identify any software required in the plant operation. It can be MIMS systems or SAP systems.
Validation of software as per GAMP guidelines including PLC validation, and QC instruments.