Life cycle assurance audits

The software life cycle activities extend until retirement of the software. However, in a manner of speaking, life cycle activities extend even beyond retirement since the data must be able to be reconstructed at any time during the life of the product, i.e., the archived record must always be accessible and readable even if the software is no longer commercially available or typically employed in the laboratory. Additional software validation includes implementation of the code and integration and performance testing. There also must be system security, change control procedures, audit trails, calibration, preventative maintenance, and quality assurance. 

To maintain control of the computer system throughout its conception, implementation, and operational use in a GMP environment, it is required that the computer system application must be validated in a way that will establish auditable documented evidence that the computer system does what it is expected to do. As applicable, this needs to be carried out in conjunction with plant equipment to provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. The methodology to achieve this is based on a recognized life-cycle mode. 

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. 

Another supporting process parallel to projeets life cycle is quality assurance. All projeets are submitted to internal audit periodieally, once or twice a year. The seope of the processes and activities audited differs depending on the charaeteris-ties and on the risk level of the projeet. 

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