Supplier Audits software development life cycle

A Source Code Review must be performed on application software unless there is evidence from the Supplier Audit that the source code has been, or will be, developed in a quality assured manner and subjected to review as part of its development life cycle. The decision and justification not to perform a review must be documented within the Validation Plan. 

Category 4—Configurable Software Packages These software packages can be conhgured according to user requirements. A supplier audit is usually required to conhrm software has been developed according to a documented quality system. Validation should ensure software meets URS requirements. Full life cycle vahdation is needed. 

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