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…
Audit Trails: OK to Generate Reports from a Back-End Database?
Q: I have a question and look forward to an answer from the FDA experts. 21 CFR Part 11 Subpart B 11.10 (e) states “Such audit trail documentation…shall be available for Agency review and copying”. For our clinical trial activities, we…
Windows 10 Validation: How to Handle Validation of Monthly Patches/Updates
Q: I have a question about Windows 10 validation. In your FDA Auditing of Computerized Systems and Part 11 /Annex 11 class, you pointed out that the “environment” for software/hardware is important when it comes to validation, because a different environment…
Complaint Investigation: When You Don’t Have to Investigate Every Complaint
Q: Does every complaint require some kind of complaint investigation? A: Yes, but with some qualifications. For each complaint you receive, you should determine the extent of the problem, its impact (risk) to the user, patient or by-stander, and its validity. Why…
Can You Trust E-Signatures from Your Software Package Vendor?
Q: I have concerns about e-signatures supplied by a software vendor. Our company is using a Quality Management System (QMS) supplied by a software vendor who provides a validation package. The package shows how the QMS was validated, and the documents…