Qualification
Qualification is a crucial step in the validation process that verifies equipment and systems are correctly installed and functioning as expected, but it is not sufficient for process validation on its own.
Our Approach
Our approach towards qualification is thorough and comprehensive, ensuring that equipment and ancillary systems are properly installed and function correctly to produce expected results. We begin by analyzing the user requirement specifications and determining the necessary testing protocols for each piece of equipment. Our team conducts rigorous testing to ensure compliance with all regulatory and industry standards. We provide detailed documentation throughout the process, including reports and certificates of compliance. Our qualification services are an essential step towards process validation, ensuring that the entire process meets the predetermined requirements and consistently produces the desired outcome.
List of Protocols
We provide the preparation & execution of following Protocols applicable to the New Equipment, Machinery & Systems.
FAT
Factory Acceptance Test
SAT
Site Acceptance Test
DQ
Design Qualification
IQ
Installation Qualification
OQ
Operational Qualification
PQ
Performance Qualification
Benefits of Qualification
- Ensures equipment meets requirements
- Validates equipment performance at site
- Verifies equipment meets design specs
- Confirms equipment is properly installed
- Validates equipment performs as intended
- Ensures equipment meets acceptance criteria
Our Expertise
Our team of experts specializes in providing comprehensive qualification services to ensure that equipment and systems are properly installed, function correctly, and produce expected results. We are experienced in conducting various qualification steps, including Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Our approach is based on a thorough understanding of the regulations and standards governing the pharmaceutical and biotech industries, and we are committed to delivering high-quality, reliable, and efficient qualification services. With our expertise, clients can be confident that their equipment and systems meet the required specifications and perform to the highest standards.
