All The Process Specifications For The Entire Data Flow Operational Qualification

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Operational Qualification

Operational qualification is a series of tests performed to verify and demonstrate the correct operation of a system. Test requirements given in functional requirements and specifications. All tests must be performed before the system is released for use or sale. Depending on individual needs and the complexity of the system, operational qualifications may be combined with performance and installation qualifications. This process is commonly required during the development and manufacture of systems and devices used by pharmaceutical companies. The system should be fully capable of performing reliably within the required and specified limits. In other words, the material should behave as required and produce uniform products.

Operational qualification can be applied to test such cases as each screen of the equipment accepts the correct data entered. Also the given stream can be operated consistently through the entire workflow and the overall security of the system is adequately implemented and all the technical installations of the equipment are running as expected and giving the required output. Other sub-systems are also checked while conducting operational qualification which include; Recording system, measuring system, storage system, executive system, monitoring system and calculating system. Specific parts of pharmaceutical equipment tested include mixing equipment, scales, dryers, molds, display equipment, safety guards, and conveyor belts. The system may also check its quality measures during operational qualification for certain aspects such as using an acceptable and predetermined ratio of power or maintaining a given temperature for a given period of time and observing any variation within given limits.

Operational qualification will follow the given procedure to ensure that it has been tested and all results are accurate. It is a protocol that is highly detailed and the system has been tested multiple times in all possible aspects and by different testers to ensure that it is quickly converted into different forms. By doing so, the results obtained can be quite reliable and do not vary between testers or show variation between product lines.

The operational qualification process takes place in a phased and adequately outlined process. According to the protocol, the initial phase indicates the specific techniques to be followed in the test, the objectives of the test and the possible results of the test that will be accepted. The said protocol is accessed to ensure that all functions of the system or equipment are tested. Also, expected and potential outcomes are also reviewed to ensure they are realistic and represent all that is required when the device is operating.

After all reviews of the protocol have been completed, the examiner will follow all instructions for operational qualification. They have to keep a clear record of the results of the agreed results mentioned earlier. If a discrepancy is found between the results and the acceptable findings, it is noted and arrangements are made to review the source of the deviation.

Finally, after the review, the equipment can be taken back to the engineers who will determine the cause of the problem. Operational qualification is an important and recommended step in the process of developing and manufacturing safe and efficient pharmaceutical devices and systems.

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