How Do You Determine What IS CRUCIAL?

Is your company ready for an inspection of your personal computer System Validation program? In this article, I will offer some key tips on how to get ready for an inspection of your personal computer system validation (CSV) program. Often times, the FDA involves inspect your facility for reasons other than your CSV program. However, because so many business procedures are governed by digital systems, this issue of computer system validation undoubtedly comes up during the course of an inspection. As a total result of an increase in federal investigators, investigators are able to inspect more facilities and dig deeper into areas such as Computer System Validation.

The initial item you can prepare is something inventory list. The list itself should be structured by GxP – GCP, GLP, or GMP – so you can sort the list during an inspection or for evaluation purposes appropriately. Next, the list should include a system owner for each system so you know who’s responsible for the system and who to call upon during an inspection. Another important piece to include is the location of the computer system validation paperwork, as this isn’t only important from a storage space aspect, but also an access point of view. Under everyday operations, one should have easy access to the documentation.

During an inspection, it is paramount to have quick access to such paperwork, as investigators do not like to wait too long for documents they request. The final attribute to include in your system inventory list can be an indicator of if a system is critical. To determine criticality, it is wise to determine if a system is utilized for regulated purposes or used to make decisions as they pertain to regulatory requirements.

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Flagging these can not only help you better plan an inspection, but also better allocate your resources more effectively for the inspection planning activities. The next item you should make sure you have in place is governing Standard Operating Procedures (SOPs). You should have the following SOPs set up for conformity, and operational purposes as well as inspection purposes.

The first important SOP to have set up is the Computer System Validation SOP. This SOP should format and details the Validation Lifecycle. It should include requirements for key areas such as Intended Use, Validation Master Plan, Functional, and User Requirements Specification, System Design Specification, Traceability Matrix, Installation Qualification, Operational Qualification, Perform-ance Qualification, Validation Summary Report, and System Release Memo. Investigators will want to see that you complete certain requirements for all of your deliverables in the Validation Lifecycle.

Furthermore, they’ll turn to ensure the deliverables have the right dependencies and are in the correct order. The second SOP to have in place is the main one for Software Development Lifecycle (SDLC). This SOP should put together the steps needed to perform the SDLC for custom applications and should handshake with the Computer System Validation SOP. The third SOP to have in place is that for Change Control. The Change Control SOP should describe the procedure for managing both hardware and software in the creation environment. Furthermore, the SOP should require a Change Control Board that is accountable for reviewing and approving all changes. It’s important to add a classification of change also.