While we maintain all of the necessary documents, our customers need more than our word to ensure that our software is properly validated and compliant.
To determine that our product is truly validated, customers conduct a software audit.
In the following article, we define a software audit for GMP manufacturing, outline the audit process, and demonstrate the mutual value that software audits provide for our clients and our products.
What Is A Software Audit?
Before our customers purchase our software, they want to ensure that it is validated.
Validation ensures the customer that the software they’re interested in purchasing:
- Meets FDA validation requirements
- Accomplishes its designed purpose
- Does not demonstrate any installation or performance issues that jeopardize the integrity of production cycles, ingredients, materials or finished products.
To verify this information, the customer conducts an audit of our manufacturing software.
This type of audit reviews the software to confirm that it is validated, functions properly, and aligns with the information defined in the computer system validation documentation and standard operating procedures (SOP).
Software audits are typically conducted by the customer with the assistance of an internal auditing team or third-party software auditors.
What Is InstantGMP’s Software Audit Process?
The audit process begins with a standard request. The customer sends our team an audit plan which requests the specific computer system validation documents and SOPs they wish to review.
While we are pleased to share our validation documentation and SOPs with all of our customers, we cannot mail physical copies or provide PDFs via email. Since all of the information contained in these documents is proprietary, we instead conduct a virtual session.
In this virtual environment, we are able to share all of the requested documentation with our customers and their software auditors. During this virtual session, customers and auditors not only have access to our documents for review, they’re given control of the screen.
By having control of the screen, the auditing team is able to use the mouse to scroll up and down each document to read at their leisure, zoom in on specific areas for closer inspection, and have a greater opportunity to more closely analyze the information.
This measure of control allows the auditors to review the specific documentation to confirm that our software is properly validated. It also provides them with proof that we have a reliable quality system in place that supports the documentation and the testing that our software developers conducted.
Once the customer has had a chance to review all the documentation and ask any relevant questions, they’ll create an audit report that outlines specific topics they want to discuss further and/or any issues they want resolved.
What Are The Benefits Of A Software Audit?
In addition to providing proof of validation and a reliable quality system, the software auditing process results in other benefits.
By asking our team questions about how the software operates and the processes and logic they used to validate the software and apply our SOPs, the customers indirectly conduct their own learning session.
During their review of the various documents, the software’s functional specifications reveal certain advantages that they were not familiar with. Although they may fully understand the overall purpose of the software, they also want to know more about these individual software features in greater detail.
And so, the auditing process allows the customer to learn a great deal more about our software’s capabilities.
Another benefit of software auditing is its potential to uncover issues that we were previously unaware of.
Once we receive the customer’s audit report, we carefully review their findings. If any issues are revealed, we’ll resolve them and respond to their findings.
Many times, the findings in the audit reports prompt our team to improve our validation documentation to clarify the information for our clients. In some cases, the audit report findings motivate us to add new features to our software in response to the customer’s suggestions.
As you can see, software audits for GMP manufacturing are necessary for our customers’ peace of mind by confirming validation and the existence of a trustworthy quality system.
And, they’re also beneficial for us as well.
Through this interactive process, we’re able to have detailed discussions with our clients to help them better understand the software features, reveal any potential issues that need to be addressed, and identify opportunities to introduce new software features that improve our products.