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– Data storage: Data stored should be secured and its accessibility, readability and accuracy should be checked.Integrity of back up data and ability to restore the data should be checked.
4.3 Validation/qualification step shall include user requirement specification (URS), design specification (DS), functional specification (FS), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) for new inventories.
4.5 Below flow chart depicts the formal validation strategy: 4.6 User requirement specification (URS): URS shall be prepared and shall be evaluated.
URS shall contain requirement and specification e.g.
4.9 Below checks shall be performed during operational phase of validation.
Additional checks can be included wherever applicable.
– Data: Computer system exchanging data electronically with other system shall include built in checks for the correct and secure entry and processing of data.