One of the biggest challenges in a major project (particularly within the pharmaceuticals industry) is the precise planning, on-schedule preparation and efficient performance of test cycles: a significant part of the stipulated documentary verification of correct system functioning in compliance with the predefined specifications is created during the execution of testing.
In the case of SAP projects, the fact that this will often involve planning, coordinating and performing tests across site and even national boundaries can make testing one of the most complex tasks associated with a SAP project.
Our test management experts will support you throughout the planning and performance of testing, regardless of whether you have chosen our full implementation methodology or another implementation approach in which the test phase – critical in the pharmaceuticals environment – must be incorporated.
The test management cycle generally comprises the following stages:
At the blueprint stage, we determine how many test cycles will be carried out, what kind of tests these will include, on which specifications the various test types will be based and how to set the dimensions of testing.
Making use of SWQM decision matrices, we establish whether it is necessary to utilise test management tools, whether automated testing may be useful and to what extent the error management process needs to be supported by a tool.
At this stage, we also determine how IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) should be defined, performed and documented.
To a large extent, preparation for testing is dependent on automation (of both procedures and the necessary skill sets). Thanks to our experience with eCATT, Mercury Test Suite and Solution Manager 4.0, we are able to provide you with the most effective support available.
For the remainder of the project, the test strategy – the result of the blueprint phase – is central to all test-related activities.
At the stage of realisation, test planning and preparation is initiated on the basis of a solid testing strategy. Under the standard SWQM methodology, the dimensions of testing are set using a pharmaceutical and functional risk analysis of blueprint results. This allows us to ensure that genuinely critical functions and processes are identified and tested accordingly – and that non-critical pharmaceutical and business-related functions are not ‘over-tested’.
Our test managers specialise in developing test designs from the results of risk analyses which determine:
Where the automation of test cases is used, those which are automated and those which are carried out manually are defined in the test design.
Making reference to predefined standards, we support project personnel in the creation of test cases and expedite planning for the performance of testing. Detailed planning of test cases is essential: without this, it would not be possible subsequently to check performance.
In addition to test planning and preparation activities, progress towards establishing the right testing conditions is monitored. Only tests carried out under proper conditions can give you and the relevant authorities confidence in your SAP system and ensure the generation of ‘documented evidence’.
The indicators of a successful test are:
Good planning can cover many of these points. This is why, during testing, you need a test manager with the ability to remain calm and take the right decisions, even in highly pressured situations. The most essential requirement of all in the management of test cycles – which can often involve over 2,000 test runs – is experience. You can rely on us to make the correct decisions and ensure GMP conformity in critical projects.
Successful testing means a confident start to the cutover phase – with a strong basis of validation documentation.