Manual to Automation – Paperless Validation
In any organization, adaption to any new technology or process change has many challenges to overcome. Few challenges are listed below
- Identification of problem statement and converting it as a business use case.
- Finding the right solution addressing the problem and business challenges
- Calculation of Return on investment (ROI) from current process to new process
- Impact analysis and Risk assessment.
- Allocation of resources for the change process (Time and Material)
In my experience, the validation process initially looks very complex with huge set of documentation and manual approval process. I had the following queries during a validation process for a vender driven application (GAMP 4 category)
- Are we doing efficient way of validation?
- Are we doing risk assessment against all critical user requirement specified?
- Are we creating all the test scripts based on the URS from the scratch to challenge the software or application?
- Are we having a complete track of proposed mitigation well covered during the test case execution?
- Are we doing the periodic review to ensure the system performance as it was during the launch?
- Does a heap of validation papers ensures the product stability, data integrity and compliance?
Let’s answer the 3 questions as per the golden circle to understand more on paperless validation process.
What (Product & Service)
- Capable of maintaining electronic records and electronic signature
- Helps users to create and categories the requirements.
- Allows user to define acceptance criteria (test cases) for all the mentioned requirements
- Based on the priority, the application helps to define the risks using FMEA approach
- Have the scope to integrate with automation testing tools like katlon studio , selenium and robotic process automation.
- User-friendly web and mobile-based system, which replaces manual logbooks and handwritten signatures
- Web based system which has templates to capture the requirements
- Online system that allows user to have discussion on the requirements before they take for vendor evaluation
- Allows user to tag the test cases and upload all the proofs of screenshots and videos during the test case execution.
Why (Value & purpose)
- Solutions that support total end-to-end processes and maintain data coherency and integrity.
- Allows implementing the highest level of compatibility with the business process without compromise of any regulatory requirements.
- Having digital data enables remote teams to connect and contribute during the validation.
- This solution will be an essential part of the quality management system, which enables the organisation to simplify administrative processes, managing equipment use, maintenance and calibration and cleaning of equipment and rooms.
- To improve the quality of data for analytics and reporting and support the release of product to market
- Enables clear and transparent way of validation process right from defining the problem statement to validation summary report.
- Enables quick data access and show the test scripts and execution to the auditors. Allows any auditor to trace a specific requirements, its related risk , test cases, actual results during the execution, electronic review process and audit trial.