GAMP UK - Round Table “Agile” from an Auditors Perspective

GAMP UK - Round Table
“Agile” from an Auditors
Chris Reid (Integrity Solutions Limited)
John Andrews (Integrity Solutions Limited_
+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?
Project / Issue Management
Code Integration
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?