Agile Validation Vs Standard Validation

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Which Validation approach we apply to validate an Agile application and how it is different than standard validation approach?

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Posted by Vishal Dogra (Discussions: 2, Comments: 2)
Replied on November 8, 2017 12:00 am
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Agile application you may be referring something under development. The same needs to be established for implementation in GxP environment. For both the approach one needs to follow the risk based approach based on GAMP5
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Posted by Amit Dekate (Discussions: 0, Comments: 2)
Replied on November 7, 2017 7:00 pm
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Yes the approach is the same, only the considered parameters/factors/attributes.
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Posted by G M Butcher (Discussions: 0, Comments: 31)
Replied on November 7, 2017 7:00 pm
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. . . are different.
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Posted by G M Butcher (Discussions: 0, Comments: 31)
Replied on November 7, 2017 7:00 pm
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Validation strategy for Agile will be different as what happens in normal validation cycle your URS, FRS, 21-CFR-Part-11, Annex 11, FRA should be sign off before starting the project but this practice can not be applied for agile methodology as requirements will be keep on coming once all sprints are finalized user stories developments are done you can route all documents for signature means before starting System Integration Testing
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Posted by Shailendra Agnihotri (Discussions: 0, Comments: 3)
Replied on November 9, 2017 7:00 pm
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Agile or waterfall or scrum are SDLC terminologies and used in development. Go for GAMP risk based approach for validation
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Posted by Suyog Kudtarkar (Discussions: 0, Comments: 1)
Replied on November 9, 2017 7:00 pm
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To take full advantage, Agile should integrate development, testing and validation. SDLC should define agile process and deliverables taking into consideration key differences (e.g. User Story, in-sprint testing, Agile validation deliverables, automation tools).
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Posted by PJ Singh, PMP (Discussions: 1, Comments: 8)
Replied on November 9, 2017 7:00 pm
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