Q: I have a question about generic logins. We’re getting computers on our production floor. Some colleagues have suggested we allow one generic login for all production personnel to view and print SOPs (with a watermark) and also to print the…
Design Validation: More than Just User Testing
Q: Really, in the final analysis, isn’t design validation just user testing? A: I’ve heard that a lot lately. But it’s not true. The Quality System Regulation (21 CFR Part 820) includes requirements for design controls. The regulation requires design validation…
FDA’s Perspective on Quality Agreements between Sister Sites
Q: What is FDA’s perspective on contracts or quality agreements with sister sites — sites owned or operated by the same parent company — that supply the primary manufacturer with materials or components? When using a sister site as a…
Guidelines for Making Quality System Changes
Q: I think we understand what’s required for changes to a product design or manufacturing process. But when it comes to making changes to a quality system procedure or work instruction, we’re not clear on what’s needed prior to implementing such quality…
Are Off-the-Shelf Coding Tools Subject to GxP Regulations and Inspections?
Q: As you know, off-the-shelf coding tools are used during various stages of software development. Among them are some tools used to manage quality standards as defined in the organization QMS. An example would be SonarQube, used to manage code…
FDA Outsourcing Rules: Do They Cover More than Contract Manufacturers?
Q: Question about FDA outsourcing rules: ISO 13485 requires that when an organization chooses to outsource a process that affects product conformity with requirements, the organization must ensure control over such processes. It also says that control of outsourced processes should…