Service Details

VALIDATIONS

Qualification ensures that equipment and systems are installed correctly, operate as intended, and produce expected results.

Validation demonstrates that processes, systems, or procedures consistently achieve desired outcomes.

Equipment Qualification: We validate equipment performance and reliability.

Computer System Validation (CSV): We ensures computer systems meet the intended use and the regulatory requirements.

The qualification process can be divided into below:

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User Requirement Specifications: Qualitus outlines user needs and expectations in the User Requirement Specification (URS) for systems or processes, forming the basis for design, development, and validation to ensure compliance and quality.
Design Qualification (DQ): Qualitus confirms whether the equipment design meets the specifications and regulatory standards.
FAT (Factory Acceptance Test): Qualitus performs a pre-delivery testing process at the manufacturer's facility to ensure that the equipment meets all specifications and requirements before shipment.
SAT (Site Acceptance Test): Qualitus conducts a verification process at the client's site to ensure that the equipment operates as intended in the actual production environment.
Installation Qualification (IQ): Qualitus ensures the proper installation of equipment according to both the manufacturer's guidelines and regulatory requirements.
Operational Qualification (OQ): Qualitus verifies whether the equipment operates within the defined parameters.
Performance Qualification (PQ): Qualitus ensures consistent performance under actual operating conditions.

  

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