HVAC validation and qualification

We offer a vast range of services related to HVAC validation. All our services are top-notch, and we have a team of expert professionals who deliver all these services with an eye for detail. We are known as a premium company that performs HVAC validation according to all the laws and guidelines to avoid any legal issues with our customers. Moreover, we offer a gamut of validation and calibration services for clean room facilities and equipment which is based on a thorough comprehension of the cGMP standards. In addition to that, we have been in the industry for a long time and hence, know exactly what the customers look for when they require HVAC services.

Need for HVAC Validation

HVAC Validation is an essential part of testing a piece of equipment. Heating, Ventilation, and Air-Conditioning (HVAC) are essential to ensure that quality pharmaceutical products are manufactured. In addition to that, an HVAC system that is well-designed also offers a comfortable condition for operators. The need for an HVAC validation is also felt in association with architecture as its design influences the architectural layout in terms of items like doorways, airlock positions, and lobbies. This is because all the architectural components of a layout impact the cross-contamination control and the room pressure differential cascades. Therefore, the need for HVAC validation to ascertain the quality of equipment and pharmaceutical products cannot be stressed enough.

Design Qualification

Design Qualification is an essential step in HVAC validation. This protocol is utilized when a design has been developed according to Health and Safety as well as other guidelines to ensure that if the designed equipment is built, it will follow all of the detailed and specified requirements present in the URS and VP. The Design Qualification is basically an authentic document that proves or gives evidence of the fact that a specific design if built, will work. It must always be authored as well as executed by qualified professionals who have adequate knowledge to be able to challenge the proposed design as well as its performance. This is precisely where we come into the picture. Our extensive range of services includes qualification, commissioning and validation, all of which are particularly designed to support and religiously follow a gamut of regulation needs and industry guidelines. Our support is vast and ranges from onsite hands-on execution to the development of protocols and templates as well as the management of several validation projects. In addition to that, we offer the experience and expertise of thorough professionals who have been in the field for a long time and hence, know exactly what you need to get things done.

Installation Qualification

Installation Qualification is also known as IQ.  It is defined as the establishment of some objectives that offer evidence that all the essential aspects of installation and process, as well as types of equipment, is done as per the approval from the manager. The process also ensures that all the recommendations given by the suppliers are properly considered. The basic idea of Installation Qualification is to verify that the installation of the pieces of equipment goes as per the design that is given for the ancillary system as well as the subsystem. There are often grey areas that are found during the testing as well as the transition towards the next step which is Operation Qualification or OQ. However, if the IQ is maintained well, the progression to OQ and then to Performance Qualification (P1Q) is smoother. Therefore, it is important to build flexibility in order to have some other inspections and tests included in either IQ or OQ. This gives a lot of flexibility while planning IO as well as OQ installations. At XYZ, we offer the best solutions for the Installation Qualification with maximum flexibility to ensure that you get the best results when our experts offer you these services.

Operational Qualification

Operational Qualification or OQ is another step in the process of software validation once the step of Installation Qualification or IQ is successfully completed. This activity consists of a host of tests that must be run in a specific chronological order in order to ascertain as well as verify that particular software is operationally fit in order to be deployed to potential customers. This protocol essentially includes a collection of several test cases that verify the proper and correct functioning of a specific system. In addition to that, the test requirements of operational qualification are properly defined, and you can find them in the Functional Requirements Specification. It is also pertinent to note here that Operational Qualification usually takes place or is performed right before a specific system is released to be used. We offer an experienced and expert team of validation engineers who know how to help customers with their operational qualification requirements. We provide high-quality reports in super-fast turnaround time. We have an in-house trained team of validation engineers who offer qualification services and on-site validation throughout the world with the very best customer service that you can find today in the industry. We are ready to hit the ground running to meet all your complex requirements with ease.

 Performance Qualification

Performance Qualification or PQ is again a collection of varied test cases performed by a system under real-world simulated conditions. The rest requirements of Performance Qualification are possibly defined in the Functional Requirements Specification or the User Requirements Specification. PQ is often used as a measure to qualify pieces of equipment throughout the entire range of equipment capabilities. It is different from Process Qualification as it only pertains to the capabilities that the validation process uses. Performance Qualification can easily be called as an integral part of the process of validation, and there are a countless number of reasons as to why it should be performed by pharmaceutical plants and companies. If you are looking for effective and high-quality validation services, your search stops at VackerGlobal. We offer experienced and expert PQ specialists who carry out quality assurance services that are tailored to all your needs in a time-efficient way and at a low cost. We have been in the industry for a long time which gives us the right edge over the competition. In addition to that, we have a proven success rate with numerous satisfied customers globally. Allow us to help you in meeting all the regulatory requirements as well as prepare you for inspections and audits!

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