Setting your CSV Audit up for Success

You’ve finally found the system that your business needs to become more effective; but you need Quality Assurance (QA) to complete a Computer System Validation (CSV) audit before you can move forward. As the system owner, it is in your best interest to ensure that the audit is done as efficiently and effectively as possible.

But QA aren’t the only ones who can affect the length of the audit. There are things you can do to help QA successfully complete their audit sooner so you can put your new system into use sooner.

1.     Notify QA as soon as possible, and provide them with information about the system:

• What software is being implemented?

• Is the vendor providing any services which might require additional SOPs (e.g., helpdesk)?

• Where will the software reside?

• Is there an implementation SOW?

• Is there a support/maintenance SOW?

2.     Provide complete information about system requirements:

• How do you plan to use the system?

• Is the process covered under regulatory regulations?

• If so, what regulations apply?

3.     Provide support to the auditor(s) throughout the process:

• Check in to ensure they have what they need to complete their audit checklist.

• Respond as quickly as possible to any requests for information that you receive during the audit period.

It’s true that a system implementation waits on completion of the CSV audit, but the QA auditor isn’t the only one with the power to see it efficiently completed. As a system owner, you have the knowledge of system needs and solution features that can put your audit (and implementation) on a faster track to a successful completion.