When companies adopt new cloudware into their operations, providing a validation for their Quality Management System (QMS) can sometimes be a daunting task. While hardware can be certified and have traceability, many in the field of Quality Assurance don’t know where to begin when it comes to verifying and validating cloud-based applications.
While not all Quality Management Systems are written the same, the least complicated route to adding to your system provides the most stable process for review from internal, external, and regulatory auditors. Risk based methodologies of implementation don’t require microscopic levels of documentation to be viable.
Utilizing the strengths of the IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Production Qualification) methodology can greatly reduce the time and resources needed to properly implement Tulip, manufacturing’s first Platform-as-a-Service, into your QMS.
By keeping the scope of the integration to these three qualifications, the risks are minimized, easily reviewed, and the strength of process truly shines through.
Included in the link are examples of IQ, OQ, and PQ documentation that can show a simplified route to software verification and validation. Clear Process Solutions continually works towards Digital Process Transformation across all lines of business to allow you to do more. Integration of new, more efficient technology should never be a hurdle or a concern when it comes to making your business more agile.
The preamble for the documentation should include cloud-based security and risk analysis statements such as:
- Access to components of the solution requires mandatory company permissions
- Cloud storage data cannot be altered without permissions
- Connector functions control and record all areas and this process cannot be circumvented
- All apps built in Tulip are revision and approval controlled
As more companies move forward with their digital road map, auditors are familiarizing themselves with this new data set for review. Quality Managers will need to be able to show how the data itself hasn’t changed, merely the way it is collected.
If you have questions about data governance, workforce augmentation or workflow automation, contact the Clear Process Solutions team. We will work with you to provide future-proof, customized solutions that will help ease your Digital Process Transformation pains. If you are interested in viewing the IQ, OQ, PQ document, download it below.