The FDA called. They’re coming to do an inspection. Yikes! Now what? How do you prepare? We’ve been there. We’ve experienced the FDA Investigator’s arrival, unannounced, ready to inspect our computer systems. It’s intimidating to say the least, especially if this is your first audit. The repercussions of a failed audit can be devastating to your organization. Warning letters are … Read more
Today is Part 3, the final post of our series – How to Audit Software Vendors. This post will review three examples of how you can leverage the audit results in a risk-based validation approach. If you haven’t already, be sure to read Part 1 on Audit Preparation and Part 2 on Audit Execution. FDA Guidance on computer system validation … Read more
Welcome to Part 2 of our series on how to audit software vendors. We will focus on the main event – doing the inspection! Before you go any further, make sure you have read How to Audit Software Vendors: Part 1 – Audit Preparation. It goes into detail about what you should be doing to get ready for the audit itself. Audit … Read more
Welcome to our three part series on how to audit software vendors. In part one, we’ll review the basic processes and preparation activities. Parts 2 and 3 dig into performing the audit itself and leveraging the results. The Vendor Audit Process In general, to audit software vendors, the process is the same for each audit method. Some of the activities may … Read more
Regulatory Agencies, like the FDA and Eudralex require companies to audit software vendors of their critical software and systems. Regulated companies include several industries – Pharmaceuticals, Biologics, Medical Devices, Clinical Studies, and Blood Products – and include organizations that sell in both the US and International markets. Guidance from the FDA states that: “…the manufacturer should consider auditing the vendor’s design and … Read more
How do you audit a software vendor? Which is the right method for your company? These are some questions you may be asking yourself. The answer is “it depends”. It depends on lots of things – how much time, money and expertise do you have available for the audit? If you don’t audit your vendor, what are the risks? How critical is the … Read more
How do you choose a software vendor? And once you do, will they be able to keep you compliant? Which vendor will provide a high quality software product and protect your data? Are they going to be there when you need support? These are just a few of the questions you’re looking to answer when selecting a software vendor. But … Read more
