Applicability of a computer validation model

An element beyond the scope of the model is the retention of electronic records, but the model can be used to verify and validate the implementation of the system(s) that will hold these records. A subset of the above requirements are applicable to hybrid computer systems,1 and the implementation of these requirements have been discussed in other articles.2,3 The fundamental requirements that Part 11 establishes are as follows  

1 In hybrid systems, some portions of a record are paper and some electronic. 

2 Lopez, O, Automated Process Control Systems Verification and Validation, Pharmaceutical Technology, September 1997. 

3 Lopez, O, Implementing Software Applications Compliant with 21 CFR Part 11, Pharmaceutical Technology, March 2000. 

When determining which requirements need to be implemented, verified, and tested, the following points need consideration whether the records are held in transient memory whether the system is a hybrid system and whether the system manages electronic signatures. The following sections describe the implementation of the model. 

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See also in sourсe #XX -- [ , , , , ]

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