Our specialized field service technicians and engineers employ regulatory compliant procedures to help our customers efficiently start up and optimally run the instruments in your facility. We ensure that your systems are properly integrated and show your team how to precisely tune them to your application requirements. Our team help you assure equipment safety and performance with hands-on training and support in multiple formats.
We offer professional repair and maintenance services in the unlikely event of the breakdown of the equipment by providing original spare parts or repairing the faulty part at component level. Our engineers ensure that the repaired device meets all the prescribed industry specifications and performance standards. Besides, they also offer suggestions about the practicality of retaining particular devices or replacing them with brand new models.
Equipment not serviced timely can have a massive impact on your business. An underperforming piece of equipment can cause frequent and unpredictable down-time during operations, leading to revenue leaks that silently but sizably dent your profits. Poor maintenance can also reduce the useful life span of equipment, eventually leading to an increase in total cost of ownership.Timely maintenance and repair for your laboratory equipment is therefore necessary if you want it to function smoothly. Hence periodical maintenance is must for your equipment need to be durable and precise to ensure accurate results and flawless functioning. Our team of trusted engineers trusted and reliable service provider with the expertise, reach and speed to maximize product up-time and protect your profits.
As the pharma industry undergoes significant change, spending for innovative equipment and technologies is escalating to meet new demands. We are quite responsive to the industry demands for newer types of equipment and technologies that are more efficient, less costly, safer and able to meet new industry needs and more rigorous regulatory guidelines. Our strong team of Application Specialists are well equipped with hardware and software upgrades to increase functionality of the equipment to meet challenging regulatory needs.
Calibration is important because it helps ensure accurate measurements, and accurate measurements are foundational to the quality, safety and innovation of most products and services we use and rely on every day. Calibration improves assurance of precise measurements required in research, development, and innovation, as well as the production of millions of products and services worldwide. Our team of engineers are well versed with calibration of the instruments by using international standard and references and issuing certification with traceability.
Increasing attention is being directed towards good weighing practice in laboratories because it is one of the most commonly performed tasks. Focus on the accuracy and suitability of the weighing balance and the various elements that influence the weighing process is crucial. If you want accurate weight measurements of laboratory samples, you need to have the right kind of scales. For example, you can use an analytical balance to correctly weigh the lab samples. The accuracy and precision of the results are dependent on how reliable the weighing system is.
It is crucial that you take the right precautions and adhere to the standard operating procedures to ensure the reliability of your reports.
Several factors can affect the analytical balance and produce incorrect readings of the samples. Some include:
Weighing of samples is an important part of analytical determinations. By adopting the above-mentioned weighing practices, you can successfully eliminate errors.
Every Instrument supplied by us to the Pharmaceutical Industry are well supported by 3Q Documentation. In the highly-regulated pharmaceutical, medical devices, and clinical industries, even tiny inconsistencies can compound to serious issues without the proper qualification and validation protocols in place.
As a component of quality assurance, equipment validation is absolutely critical to producing consistent, high-quality products. One of the key set of protocols within equipment validation is Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).Before you even get to IQ, OQ, PQ, if you’re acquiring a new piece of equipment, you’ll need design specifications that define exactly what’s in that piece of equipment. Everything from the type of power source it will utilize to the exact materials used in its construction. Once you have your final/approved design specs, you order the equipment, it comes in and now you’re developing your IQ and OQ. Quite often, the basis for the IQ and OQ will be the equipment manual itself. To save time and, prior to delivery, we’ll ask the equipment manufacturer for the manual and we’ll use the manual as the basis of our protocols.
IQ, OQ, PQ protocols are methods for demonstrating that equipment being used or installed will offer a high degree of quality assurance such that production processes will consistently manufacture products that meet quality requirements. Since these concepts are complex, it’s best to understand them one-by-one.
Newly installed or modified equipment must first be validated to determine if it’s capable of producing the desired results through Design Qualification (DQ)—a protocol defined as the documented verification of a proposed design’s ability to meet the requirements it needs to fulfill.But how a particular unit of hardware or software performs in real-world scenarios depends on the installation procedure. Installation Qualification (IQ) verifies than an instrument or unit of equipment being qualified (as well as its sub-systems and any ancillary systems) have been installed and configured according to the manufacturer’s specifications or installation checklist.For example, a physical instrument or tool may require a specific amount of floor space, certain operating conditions, and an assurance that no damage exists on the unit. For software, IQ typically involves (but is in no way limited to) verifying folder structures are correctly established and ensuring that the minimum system requirements are met.
Regardless of whether it’s a physical unit or software being tested; the FDA’s IQ definition offers a useful statement of the overall goal: documenting that the “system has the necessary prerequisite conditions to function as expected.” Along with this, any CGMP requirements relevant to the IQ—and the methodology used for IQ—must be documented thoroughly in the Validation Master Plan (VMP).
After the initial IQ, re-qualification must be performed following any major maintenance or when equipment is modified. Re-qualification should also be performed as part of routine quality assurance processes.
Successful IQ is typically measured by how well the installation process followed the manufacturer's guidelines and met their requirements.This often includes (but is not limited to) the following areas of focus:
Operational qualification (OQ) is performed after meeting each protocol of IQ. OQ’s purpose is to determine that equipment performance is consistent with the user requirement specification within the manufacturer-specified operating ranges. In action, this means identifying and inspecting equipment features that can impact final product quality.During OQ, all items in the test plan are tested and their performance is thoroughly documented. Since this is a prerequisite for acceptance of equipment and the facility, it can only be conducted once the IQ is run.In general, OQ serves as a detailed review of hardware or software startup, operation, maintenance, cleaning and safety procedures (if and where they’re applicable). Every unit of hardware and software must be shown to be operating within the specified limits.
As explained above, the action items of OQ are identifying and inspecting the components of equipment that impact product quality and ensuring they’re operating within specific limits.
These often include (but, again, are no way limited to) the following:
The final step of qualifying equipment is PQ. In this phase, the qualification and validation team verifies and documents that the equipment is working with reproducible results within a specific working range in simulated real-world conditions.Instead of testing components and instruments one-by-one, PQ tests them all as a partial or overall process. Before they start qualifying, however, the team must create a detailed test plan based on the process description. It’s important to note that the quality of the qualification depends in large part on the quality of the test plan. This is one area where a third-party specialist can (and often should) be brought in to ensure thoroughness and accuracy.The Process Performance Qualification (PPQ) protocol is a fundamental component of process validation and qualification. Its purpose is to ensure ongoing product quality by documenting performance over a period of time for certain processes.
Our specialized field service technicians and engineers employ regulatory compliant procedures to help our customers efficiently start up and optimally run the instruments in your facility.