GAMP UK - Round Table “Agile” from an Auditors Perspective Chris Reid (Integrity Solutions Limited) John Andrews (Integrity Solutions Limited_ firstname.lastname@example.org email@example.com +44 (0)7771 855300 More and more suppliers are adopting or claiming the use of Agile methodologies? Can we accept this? The dreaded documentation trolley. Who is it for, developers or auditors? Vs. Project / Issue Management Code Integration Testing Vs. Requirements, Design and Test information is maintained in electronic form within various tools supporting the Software Development Lifecycle. The control of such electronic information is not defined within SOP-XXXX, Product and Software Development Lifecycle. Further, paper documents are printed and signed for use during external audits. It was acknowledged that electronic documents are the primary records used during development. Options for resolution? Electronic Requirements Specifications are accessed via the [Issues Management] Tool. An electronic Requirements Specification was reviewed within the tool and still contained tracked changes. The equivalent paper documented did not contain tracked changes and was approved. Options for resolution? Quality Center contains test plans and scripts that are executed within Quality Center. These plans and scripts are exported to paper documents where they are reviewed and approved. The review of paper documents does not confirm equivalency with the content of Quality Center. Further, although tests are actually executed within Quality Center there is no evidence of retesting following failed tests. Only evidence of the final test run is retained. All test runs and test status should be reported within Quality Center. Options for resolution? Release x.x.x Design Specification was approved on 8th April 2009. The code review was approved November 2008 and Module Testing of the XXXXXX module was conducted in March 2009. The Design was not finalized until after Coding and Module Testing. Options for resolution? What happens when a company adopts Agile having followed a traditional methodology 7 years into the life of the product? Are these issues specific to Agile?