Is Cloud Testing a good option for SAP application's speedy testing in Pharma validated environments?
Pharma organizations' typical pain point in IT deployment is that it takes a huge amount of testing to fulfill all the Computer Validation requirements as per the 21 CFR Part 11 guidelines. Testing cycle contributes ~40% of the application deployment cost and ~ 50% of the project timelines. The duration of an SAP implementation project in Pharmaceutical organization is atleast 20-30% longer and costlier than the similar project in engineering industry.
So what are the ways to reduce these timelines, effort and cost?
Let us look at the types of testing cycles involved in SAP implementation for a Pharmaceutical organization.
- Unit Testing
- Informal Screening &Formal Screening of scenarios
- End to End Integration Testing
- Performance testing
- UAT
- Mock Runs
The formal screening of scenarios is to ensure satisfactory testing as per the regulatory needs and it consumes lot of testing effort. The business scenarios which are GxP impacted have to be tested formally with extensive documentation which adds up to the testing effort. Apart from it, it needs hardware to comply with certain installation qualifications and operational qualifications (IQ and OQ) which takes more time for environment preparation compared to environments in non regulatory industries.
In such a scenario, does cloud testing help to reduce the timeline and cost?
Cloud testing is utilized to reduce the timelines and effort of testing cycle by creating virtual labs in the cloud. The virtual resources are leveraged to reduce need of purchasing and maintaining your own hardware. However, organization needs to ensure that the environment comply with the IQ , OQ and PQ (performance qualification) requirements. If the service provider offers a specialized service for Pharma organization, it would certainly help reducing the time and cost of environment preparation. While doing so, organization needs to emphasis on due diligence and getting the requirements fulfilled on Security, privacy concerns, lack of control etc.
What could be done to optimize the formal testing and documentation requirements?
Apart from it, the impact of business scenarios has to be clearly specified considering GxP relevance. Infosys' SAP Life Sciences Practice offers a solution which helps identifying the GxP impacted scenarios and optimize the formal testing effort. The rational utilized for assessing the impact follows cGMP, GLP and GCP and the solution could be modified to include organization specific criterions to make it more suitable for organization's requirements. This reduces the time needed to come up the list of scenarios for Formal Vs Informal testing.
So cloud computing and Infosys' solution together could be an answer to reduce the testing timelines as well as cost in SAP implementation projects.
