Csv usr, iq, oq, pq

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URS, IQ, OQ & PQ refer to different qualification stages that companies use to ensure systems and equipment are suitable for their intended purposes. User Requirements Specification (URS) involves capturing the functional and performance needs. Installation Qualification (IQ) focuses on verifying that equipment is properly installed. Operational Qualification (OQ) tests functionality and performance. Performance Qualification (PQ) confirms the system can reliably operate under actual use conditions.

This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations. Several approaches to software validation exist and may be appropriate for a specific project. The scope of any validation effort depends upon a number of factors Size and complexity of the software, Origin of the software (custom vs. off-the-shelf) and Whether the functions are critical or non-critical in nature. By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.

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