The FDA encourages a risk-based approach and critical thinking in Computer Systems Validation and promotes efficiency. Using digital validation tools and adopting paperless validation helps not only meet FDA regulations but also promotes efficiency, consistency, and audit readiness. “This draft guidance is intended to: Describe ‘computer software assurance‘ as a risk-based approach to establish confidence in the automation used for … Read more
We are excited to be returning as a sponsor at the 2019 SQA Annual Meeting in Atlanta, GA next month. If you are attending this conference, stop by our booth. Our team would love to meet you and answer any of your software quality assurance or computer system validation questions. Visit us in Booth #309. Additionally, Deb Bartel will be … Read more
If you have purchased or are planning to purchase a computer system for use in regulated activities, here are some key points to keep in mind. As the regulated company, your responsibilities differ from those of your vendor. There are examples from multiple regulatory documents regarding cloud and SaaS computer systems. 1. You are ultimately responsible (not the vendor) As … Read more
We are a sponsor at this week’s 2018 IVT Data Integrity Validation conference. Deb Bartel and Joe Cunningham will be in attendance and are looking forward to discussing your data integrity and validation needs. More about the conference: With FDA and MHRA attention pinpointed on data integrity issues in recent 483s and warning letters, it is critical to prepare your validation and … Read more
We are thrilled to announce another speaking opportunity for Deb Bartel this summer. She will be speaking at the Midwest Regional Chapter Society of Quality Assurance Annual Conference during July 24-25th. Additionally, we will have a booth where Deb and Jamie Morris will be on hand to meet attendees and learn about their software quality assurance and computer system validation … Read more
Companies who are are new to computer system validation often ask us whether software validation is required for their specific software or systems. And they often assume that they must validate their entire system. While that assumption makes perfect sense, it is not always correct. More on that in a bit. But first, we must understand what types of systems … Read more
Life Sciences companies that want to sell their products or services in the United States must comply with the 21 CFR Part 11, Electronic Records and Electronic Signatures regulation. This includes systems used in researching, manufacturing, and distributing product such as pharmaceuticals, medical devices, biological products (e.g. vaccines), blood, and tissue (e.g. organ transplants). It is critical that the professionals who … Read more
Computer System Validation (CSV) is often referred to as software validation. Regulated companies perform validation projects to prove that their software or system is performing the way it is supposed to work, and not performing in ways that it isn’t intended to work. There are several examples as to why software validation is important. Look at the FDA’s library of … Read more
Computer system and software validation is about the patients and the products we make for the patients. As consumers we want to trust that our medicine, medical devices, instruments our doctors use, and so forth, work the way we expect them to work. There are product recalls for so many things – product recalls for food, toys, and even vehicle … Read more
We are looking forward to being a sponsor at the 2018 IVT Computer and Software Validation conference in Philadelphia. This will be our second time attending as a sponsor, as we met a lot of great people at last year’s conference. Team members Deb Bartel and Joe Cunningham will be in attendance and are looking forward to meeting new faces. … Read more
We are excited to be a sponsor at the 2018 SQA Annual Meeting in Anaheim, CA next month. If you are attending this conference, stop by our booth. Our team would love to meet you and answer any of your software quality assurance or computer system validation questions. Visit with Deb Bartel and Joe Cunningham in Booth #402. And we … Read more
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
The FDA sends Warning Letters and 483s to companies who significantly violate FDA regulations. We gather those related to computer system issues so that you can help ensure your organization doesn’t fail an inspection for similar violations. Organizations who received warning letters citing computer system issues: Wockhardt This Warning Letter cites the failure to validate 12 systems. Download this warning letter. Zyno … Read more
At the end of 2016, the FDA published Guidance for Industry and FDA Staff, Postmarket Management of Cybersecurity in Medical Devices to inform industry of recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. This guidance emphasizes that manufacturers should monitor, identify and address cybersecurity vulnerabilities and exploits for their medical devices. What is in the FDA Guidance Document: This … Read more
