Computer Software Assurance: The Next Steps for Better Compliance
Thursday and Friday, 22 and 23 September 2022, 8:00 AM-5:30 PM on Thursday and 8:00 AM-1:30 PM on Friday
This symposium was delivered on 22-23 September 2022 in Raleigh, NC hosted by SQA’s Computer Validation and IT Compliance Specialty Section (CVIC). The purpose of this symposium was to develop a better approach to computerized system validation based on the initial discussions between the US Food and Drug Administration (FDA) and the Medical Device Industry. A few concept publications had been published on CSA and the U.S. FDA had released a much anticipated draft guidance document on the topic. SQA set up a Rapid Response Team to prepare comments to the agency.
The new guidance document references two other guidance documents by FDA – General Principles of Software Validation and Validation of Automated Process Equipment and Quality System Software. While the focus of this guidance is on medical devices to promote product quality and patient safety, the ramifications are much larger for regulated industry. This symposium explored practical steps towards compliance.
The symposium will consist of the following four sessions.
SESSION 1:
- What in validation may change with implementing CSA?
- What in validation may not change with implementing CSA?
- What does CSA mean to you?
SESSION 2:
- What does the future look like for CSA?
- What will the new testing paradigm be (Fit for use)?
- How will electronic CSA validation deliverables have documented?
- What is the right level of validation documentation?
SESSION 3:
- What are the right Metrics for CSA?
SESSION 4:
- How should audits of CSA be planned, conducted, reported?
- What Metrics can be used from Session 2 to assist in auditng?