Validating computer systems Blond edmonton dating
In other words, computer systems should be validated during the entire life of the system.Because of the complexity and the long time span of computer validation the process is typically broken down into life cycle phases.costs for systems with different impact and risk on product quality.
It has been developed by inspectors for inspectors of the Pharmaceutical Inspection Convention Scheme (PIC/S) but is also quite useful for the industry.This primer gives a good overview and lists major validation steps and tasks but for an in depth understanding and for easy implementation readers are recommended to read further references, for example the SOPs and validation examples as included in the Computer System Validation Package from Labcompliance.Validation of computer systems is not a once off event.Several life cycle models have been described in literature.One model that is frequently used is the V-model as shown in figure 1. V-Lifecycle model This model comprises of User Requirement Specifications (URS), Functional Specifications (FS), Design Specifications (DS), development and testing of code, Installation Qualification (IQ), Operational Qualification(OQ) and Performance Qualification (PQ).
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It has more than 50 pages and includes a six page checklist recommended to be used by for inspectors.