Hyper Automation- How it can change the CSV forever.

Hyper automation can help to address the biggest pain point in CSV, TIME investment and of course a bit of Cost as well . Hyper automation can play a significant role in improving time taken in the CSV process by automating various tasks and reducing the risk of errors. Following are the wide processes where the hyper automation can be implemented, in coming articles I will discuss each one of these in detail:

1.??????Risk assessment: Hyper automation can help automate the risk assessment process by extracting data from various sources and analyzing it to identify potential risks. This can help reduce the time and effort required for manual risk assessment and improve the accuracy of the assessment. This can be done for complete process from System Risk assessment to Functional risk assessment. While automating the process we need to think from complete process automation encompassing factors like?application GXP relevance, vendor maturity, application maturity, userbase, previous history on incidents ( to calculate stability and reliability of application) .

2.??????Documentation: Hyper automation can help automate the documentation process by generating test scripts, validation plans, and other documents required for CSV. This can help reduce the time and effort required for manual documentation and ensure consistency across the documentation. We can see, Validation summary reports, configuration specs, RTM in this area.

3.??????Testing: Hyper automation can help automate the testing process by generating test data, running test scripts, and comparing results against expected outcomes. This can help reduce the time and effort required for manual testing and improve the accuracy of the testing. Imagine a situation when your test script generation, mapping, execution is managed by system based on risk profile, historical data lake and library of test cases.

4.??????Change management: Hyper automation can help automate the change management process by tracking changes to computer systems, identifying the impact of changes, and ensuring that all changes are properly validated. Most importantly, while executing change controls, the impact and traceability of change on requirements, associated interfaces and testing can be determine by hyper automation to an extent that the test plan is auto created to incorporate all impacted elements. Imagine a process automated that the moment you change a requirement or introduce a new feature, system gives you a list of impacted URS, FRS, Test cases, CS and DS sections and creates a draft for you to review. Also the system prompts you if are closing a CR and missing section which you should have tested.

5.??????Audit trails: Hyper automation can help automate the creation and maintenance of audit trails by capturing data from computer systems and storing it in a secure, tamper-proof format. This can help ensure that all activities related to computer systems are traceable and auditable. hyper automation can help to address the big-time consumer Audit trail review, we can configure the process to a extent that based on critical transactions and it can also take care of bigger Data integrity challenges in audit trail review like contemporary and legitimacy.?

6.??????Periodic Review: By automating the periodic review of the application based on the predefined criteria such as risk profile, frequency of changes, GAMP Category and so on. Based on the periodic review, it can generate alerts or even further take corrective actions.

7.??????Incident and discrepancy management: A well-defined, complete automated process can help solve one of the ignored but typical challenge of Incident management. Image an automated workflow to capture incident in click of a button, fill your incident report electronically. The Hyper automation kicks in, based on available data, the suggested RCA pops up and you can also use trend analysis to predictively prevent incidents. We will discuss them in detail in coming articles.

As you can see the opportunities are endless, in coming articles, let’s look at each one of these. What are your pain areas??if you can comment we can discuss them as we go on.?