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Pharmaceutical, Life science and Healthcare are few of the industries which need to ensure that they are fulfilling the recommended guidelines of various regulatory and quality standards like FDA, USFDA, MHRA, TGA and many more. Now a days the whole industry going through the transition period of process automation. The whole industry is very eager to bring automation and redesign its various manual processes like batch recording, audit management, quality management, document management, training management, adverse effect recording, dossier management and many more. According the good automated manufacturing practices (GAMP) guidelines published by the International Society for Pharmaceutical Engineering (ISPE) any software which is being used for any process automation should be validated and documented properly to ensure that the system is fit to deliver the expected result. Let us learn more about Role of validation protocol in software validation
Validation protocol is the process to test the software and documented it in accordance with GAMP guidelines to ensure that software is meeting all the expected outcomes.
A validation protocol is an approved document which summarizes the program to be carried out, the test to be done and the acceptance criteria for those tests are:
DQ- Design Qualification
IQ- Installation Qualification
OQ- Operational Qualification
PQ- Performance Qualification
It is the process of documenting design reviews to illustrate that all quality aspects have been fully considered at the design stage. The purpose is to ensure that all the requirements for the software have been clearly defined at the start.
The installation qualification (IQ) protocol verifies the proper installation and configuration of software and documenting the actual installation of the software, the hardware capabilities and supporting infrastructure like networks and backups appropriateness.
The operational qualification (OQ) protocol is a process of collecting and documenting test cases used to verify the proper functioning of a software.
Performance Qualification (PQ) is the final protocol that needs to be performed, once the software is being used in production and documenting it to ensure that your software performs incessantly as expected.
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