What is critical thinking?
Critical thinking is a concept that when applied to CSV means analysing the business process, mapping out the flow of data and thinking critically about the risks when validating the process - and then applying a flexible approach to the validation process which considers risks to patient safety, product quality and data integrity.
The challenges you may face.
There is a temptation when looking at the validation process for a business system, to simply follow SDLC procedures and fill in documents and templates by rote. Timing can be a big challenge, especially when mapping out the process in sufficient detail in the early phases of a time critical project, (especially when availability of the right business process experts may be limited).
Things to consider:
- Understand the whole business process including entry and exit points for data flows.
- Understand the connections into and out of the system.
- Follow the data. Adapt “standard” templates or discard them.
- Don’t overload testing with too many screenshots – they won’t necessarily add value.
- Make best use of the system supplier – they know their products best.
- And remember – Critical Thinking is just thinking objectively & applying common sense!
The Solution
Make an initial assessment as to whether the business system actually warrants the validation effort being considered.
Ensure Business Process and Data Flows are defined to ensure a full understanding of Business Processes that can be translated into User Requirements for Implementation. Deep dives into subprocesses and interfacing processes will provide a basis for a focussed drive on key processes and data.
User Requirements can then be developed with the emphasis on relevance to the process and the identification of critical (audit trail necessary) processes and data.
Make the best use of the supplier(s), they are the experts in their own applications and have significant experience from multiple client implementations. Leverage their product knowledge and try to minimise customisation by using Critical Thinking during Risk Analysis to establish whether to go back and redesign the solution or accept the design and manage in the testing strategy – think about the business need, can a standard solution be used?
If the supplier has demonstrated that their QMS processes meet quality expectations, then making use of testing already carried out will make customer testing more effective and focussed, and will aid requirement traceability.
Testing – use Critical Thinking to develop appropriate risk-based tests to demonstrate the patient safety, product quality and data integrity of the system. Focus on “proving steps” (use exploratory testing and unscripted vs scripted testing) and try to use automated test tools where possible to maximise project efficiency - allowing for a better test review cycle and hence delivery of a product that meets the business need.
Finally, do not hesitate to adapt standard templates and documents to the needs of the
system or process being validated, not the other way around, and only deviate if there is a
critical business requirement, regulatory or legal requirement.
The Outcome
By working through the business process and its associated data flows, a full understanding of the system will come and thus allow for a true risk-based approach to the regulated aspects of the system and how best to validate it, i.e. using the tools and processes that work best together to demonstrate patient safety, product quality and data integrity.
The role of 'Critical Thinking' in the validation process brings a logical and structured method to the approach when considering the system/process to be validated - focussing on the key areas of the process and assuring that a true risk-based approach is followed. As a result, delivering a solution that the business can deploy with full confidence, knowing that it is fit for purpose.