Identifying Potential Automated Processes for Software Validation

Based on the above discussion of FDA regulations and guidance, IVD manufacturers should assess their implementation of software in automated processes that are used in production and the quality systems. One identification method is to inventory all software used in a facility, whether it is stand-alone (e.g., on a workstation or server) or for automating a manufacturing process. After all software is identified, an IVD manufacturer can assess whether the software is used in production or the quality systems.

Another identification method that may be more efficient is to assess the implementation of the quality system requirements and identify the automated systems that implement those specific requirements. Such an assessment can be conducted using a checklist (see Figure 1). Based on 21 CFR 820, the checklist has columns for the applicable part 820 section, potential software implementation or record-related requirements, identification of applicable software and systems, software validation responsibility, system risk, and priority. With such a checklist, each automated system related to the implementation of quality system requirements can be recorded, identified, and managed.