How software validation processes can be shortened by focusing on risks and critical points

Real-time Challenges in moving to a more advanced digital solution:

The fast pace changes in the processes and operations have impacted every industries in terms of optimizing their budget, resources, management, continuous trainings, provisioning self-learning access on job etc. The current evolution is mandating the operations and every involved person in process on their toes all the time. ?

Process oriented companies and the operations which are into the compliance mandate are still somewhere struggling to implement the solutions in this constantly updating technology and processes. Many organizations are still clung to the old style processes and notes in order to manage their operations, whereas the reluctances among person involved to manage the process is equally pulling the entire workforce at the back seat.

In most of the cases, the people are very much used to the outdated processes and one never feel comfortable moving to the advanced and more volatile processes where a lot of efforts and delays can be averted. One more concern that keeps pulling people from stepping to the more digitized and updated system is the automated key performance indicators and trend that gets captured of individuals work strategy and deviations. Hence, it becomes much difficult to convince the workforce followed with continuous pitching of the positive outcomes and the long-time benefits.

Whereas, doing adjustments, compromises and replacements on paper based record is much easier than being in the system where the system captures the reason behind the change with date and time stamp.

In many cases still the validation approach and the scripted validation with its timeline from end to end bothers the operations to take decision to update their operations to digital.

Current Industry Practices:

The continuous development and implementations in digital solutions and the utilization of automations in Healthcare, Clinical, Pharmaceuticals, Business and other manufacturing and inventory processes where the event capture is an epitome to the entire operations, have made it much challenging to manage the continuous and step by step validations. Every implementation raises the concern among Quality person and end users about the complete flow review, documentations, team allocation etc., while managing the daily business processes along for the solution implementation. ??

Still most of the organizations are on paper based data recording systems, where they spend a lot of time in compiling and on its maintenance and movement form one person to another. No matter, the business continuous to grow, but definitely the outcomes can be multiplied if moved to the more advanced and automated processes to achieve the short term or long term goals.

Then focus on directly involved and networked quality attributes makes the tracing and final conclusion more cumbersome to finish the validation of the application. In many cases the validation team still believes in stacking lots of documents with least focused on the quality output of the product whereas in some cases the main focus is on maintaining the quality output while adhering to the minimal required documents.

Advanced Practices to be utilized:

The current problem among the industries is the lack of critical thinking and the old standard operations that mandates the validation of the solutions from end to end.

The critical thinking and constant involvement of the end users to pin point the possible risk areas and the most critical parts of the operations if focused for assessment can help shorten the load at validation side and can save ample of time at every level. There is something that can be achieved with out of the scripted process of validation while maintaining the most required assessments and process documents for compliance.

Training among peers can also help the workforce gain knowledge and confident followed with thinking of adapting the latest processes. This would also help automate the KPIs and outcomes on individual basis and can help pull the reports on click for entire accountability.

-???????People shall get rid of the fear of audits and scripted approach of proving the processes, rather the focus shall put on setting benchmarks and let the auditors attest the wonders! ?

-???????Focus shall be on to prove the actual system and its functions and accountability reports but not much on the stacked scripted validation documents and checks. No doubt, the necessary set of software ?supporting documents shall be made available.