Q: We recently audited a prominent Electronic Data Capture (EDC) software vendor. We were discouraged to learn they’ve restructured their QA group such that the QA oversight role is greatly diminished. For example, the vendor no longer schedules annual internal audits…
Tag Archive for Suppliers
Supplier Evaluations and Audits: Roles, Requirements and Limitations
• 2 Comments
Q: Could you explain the difference between supplier audits and a supplier evaluations? As I recall from attending your training classes, you’re a proponent of evaluations. Could you explain further? A: It’s not so much that I’m a proponent of supplier evaluations…
Quality System Maintenance: What Activities Does FDA Expect to See?
• 0 Comments
Q: Section 820.5 of the Quality System Regulation says that we must establish but also “maintain” a quality system appropriate for our product. Some of the things we should maintain seem obvious, but I’m curious — from your perspective as a…
COTS Software System Validation: Can You Rely Just on Vendor Documentation?
• 0 Comments
Q: In 2016, I attended the EduQuest class on FDA Auditing of Computerized Systems. During the class we discussed the importance of clinical study sponsors to validate computerized systems used to satisfy (or assist with) specific business processes. In June 2017, FDA issued…
SCADA Qualification and Upgrade: Can You Qualify a System While It’s Live and On-Line?
• 0 Comments
Q: If we perform a modification to a qualified SCADA (supervisory control and data acquisition) system, can we use the SCADA system while it’s still on-line — and also while we are performing the SCADA qualification? A: The SCADA software manufacturer should…
FDA Rules for Tracking Exchanged Parts: Are You Servicing, Remanufacturing, or Refurbishing?
• 0 Comments
Q: Are there any FDA regulations or requirements that cover the tracking and recording of exchanged parts used in equipment such as medical devices? A: The current answer depends on whether you are servicing the device, remanufacturing it, or refurbishing it. If…
FDA’s Perspective on Quality Agreements between Sister Sites
• 0 Comments
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…
Are Off-the-Shelf Coding Tools Subject to GxP Regulations and Inspections?
• 0 Comments
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?
• 0 Comments
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…
Can You Trust E-Signatures from Your Software Package Vendor?
• 0 Comments
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…