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, 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

Mode of Services

Services A

• Meeting with client.
• Identify Clients and respective regulatory requirements.
• Define Qualification/ Validation requirements and make sure it’s implementation.
• Post visits to for the verification of effective performance of equipment and utilities.

Services B

• Meeting with client.
• Identify Clients and respective regulatory requirements.
• Define Qualification/ Validation requirements and make sure it’s implementation.
• Appoint fulltime Sasaglobal team at the site till the work is completed.
• Prepare URS, FAT, SAT, IQ, OQ & PQ protocols.
• Our engineers perform FAT with client.
• Execution of FAT, SAT, IQ, OQ & PQ, compile report and submit to client.
• Post visits to for the verification of effective performance of equipment and utilities.