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Process validation is a defined process in which the collection and evaluation of the data are done. Process validation is about establishing documentary and scientific evidence. It is the capability of delivering quality products with consistency right from the start till the end. Process validation is an activity that is completed in three stages.
The first stage is the process design at which knowledge is gained through the whole developmental procedures. The second stage is the process qualification at which the capacity of manufacturing is evaluated. Third and the last stage is continued process verification. At the third stage of the process, validation assurance is also done. Assurance is mandatory in order to keep the whole process in a state of control.
Process validation is considered as the key process with which quality assurance can be possible. In process validation, there are certain series of steps followed. Based on the stage of the product life cycle, there are four types of process validation.
1. Prospective validation
2. Retrospective validation
Process validation is mandatory for producing high-quality products. Testing does not guarantee the quality of a product. Process validation is a tool that can ensure quality management for products. Process validation is completed in phases. These phases are:
1. Qualification Phase
2. Process Validation Phase
3. Validation Maintenance Phase
I need two separate bits of help in this project- 1. I need someone who can explain me below topics concerning FDA ISO Standards 2. Also, prepare the sample documents for the following points. 1. Installation Qualification Protocol Document (IQ): 1.1 HVAC calibration 1.2 HEPA filter integrity test 1.3 Site Acceptance Tests(SATs) 1.4 Installation Qualification tests 1.5 Piping and welding docum...