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.

Commissioning Support:

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

Automation requirements:

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.

Software validation:

Validation of software as per GAMP guidelines including PLC validation, and QC instruments.