Validating the acceptability of a software product
Here you will find the philosophy of validation, responsibilities, validation approaches of design qualification, installation qualification, operational qualification, performance qualification, cleaning validation, method validation, computer validation, general and specific criteria of validation, validation documentation and change control, validation reporting, guidelines of validation acceptance criteria.
Following is a list of manuals and procedures linked with sample pages.The aim of this validation guideline is to provide a clear statement of the scope, validation approach and testing requirements for the validation of the equipment that is involved, directly or indirectly, in the manufacturing and testing processes.The plan pertains to the qualification of processes and laboratory equipment.Parts of this procedure may not always be executed at the same time (e.g., The storage tank for the purified water may be cleaned and passivated without cleaning and passivating the ringmain).The scope of this procedure includes the validation of 1.This procedure has practical instruction on Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to be performed by the qualified equipment service technician in the presence of the laboratory staff with reference to the instrument/equipment manual.
This procedure describes in detail the procedures for the procurement of equipment, incorporating standardized demand specifications and Installation Qualification documentation, to ensure that equipment procured complies with in-house requirements and standards and conform to Good Engineering Practice, to detail the general procedure to be followed regarding the reporting of Factory and Site Acceptance Tests, to detail the manner by which the equipment Installation Qualification is documented.
The procedure may be performed after construction, following invasive repair or following maintenance.
The various parts of this procedure are to be performed as necessary.
concurrent and prospective validation) and qualifications (OQ, PQ).
This SOP defines the procedure for cleaning, passivating and derouging the purified water system at a GMP site.
The purpose of this SOP is to define common procedures to follow when organizing Trials/Evaluation Studies for the purpose of process improvement, equipment capability and validation studies.