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CSA new guidance release
On September 13, 2022 the FDA released a draft guidance, "𝐂𝐨𝐦𝐩𝐮𝐭𝐞𝐫 𝐒𝐲𝐬𝐭𝐞𝐦 𝐀𝐬𝐬𝐮𝐫𝐚𝐧𝐜𝐞 𝐟𝐨𝐫 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐒𝐲𝐬𝐭𝐞𝐦 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞". It is evident from the initial reaction following the release that this guidance has been awaited by the industry for years.
Using Automation in Validation of Cloud Based Quality Systems
Cloud technology is an enabler for ongoing process improvements, consumer end-product price reduction and is a part of the ongoing Industry 4.0 revolution. Regulated industries, such as life science, food & beverage, cosmetics and tobacco are often very conservative when it comes adopting new IT systems and trends. Cloud computing is no different, although recent years have seen a shift in adopting cloud-based technologies in these industries.
Computer Software Validation Automation - Q&A
A Q&A session about CSV automation, last update July 28, 2022
From computer system validation to computer system assurance
Technology is evolving. Newly purchased IT systems these days are mainly cloud based, making on-premise servers (and associated costs) redundant, enabling easier upgrades, allowing faster deployments, easier modifications according to customer requirements and providing end-to-end solutions (hardware and software). Companies that operate under strict regulation, such as life sciences, food & beverages, cosmetics and tobacco have traditionally been slower on adopting new IT systems.
Moving to cloud based applications
The biggest fear companies deal with when moving to cloud apps is related to losing control over their applications. How can we maintain ownership while a third party has the ability to change our application? The answer is creating a process that gives you better control over the system without stopping or delaying updates. The foundation for this process is a risk based approach.
Modernize risk management in software validation
As SaaS becomes increasingly popular and companies are relying more and more on SaaS platforms, managing risk has become essential.
From CSV to CSA
Traditional CSV is perceived as a burden that companies do to check the box and successfully pass audits, not necessarily improve the quality of deliverables. Companies tend to perform it only when they must, actually delaying new projects and adoption of new technologies. In the era of cloud computing, where updates are usually pushed by software and app vendors on a regular basis, customers don’t always get to decide which updates they would like to embrace. Some companies consciously decide to be at risk and do not perform an impact assessment of every release.
The Future is Coming: Software Validation Automation
CSV. You know it. You have probably done it dozens of times. You probably understand the importance of practicing it. However, it’s a very time consuming and burdensome process. Not only does it eat up your time, you’ve probably run into a range of issues around it including:
Salesforce Computer System Validation in 2020 – Why? When? How?
The Salesforce platform receives updates 3 times a year automatically. Prior to these updates, Salesforce customers may ask for a preview of the next release in order to test and evaluate the impact of the release on the different installed applications. In addition to Salesforce, Salesforce-built applications (created by Salesforce partners) may also be updated from time to time, depending on vendors’ schedule and other considerations.
Increasing software quality and accuracy using automation
With rapid changes in technology and industry needs, new tools can be used to improve the methods used to ensure software quality until recently. Instead of asking a system administrator or a software provider to identify system risks and write a plan to mitigate and test these risks, new tools can be used to analyze systems, identify high-risk elements and suggest ways to mitigate and test these risks.
Reveal the Unknown-Unknowns - The Risks in SaaS Based Applications
For regulated companies, validating computer software may be a burden but it is also a necessity. One of the most crucial aspects of software validation is risk analysis and identifying areas that might be impacted by software changes and upgrades. In SaaS solutions, where applications usually come pre-built as an out-of-the-box solution and one-size-fits-all approach, it becomes impossible for professionals to successfully identify all the risks associated with the software and platform they are implementing.
CSV automation – It’s (not) all about the money
Automating manual processes is a significant motive for innovation of technology, especially for IT organizations. However, for regulated companies, using innovative tools may include risks and concerns, leading to slow adoption of new solutions and tools. In the past years, more companies are embracing a risk-based approach and have implemented modern solutions to digitize and automate their processes.