Validation is essential in maintaining the quality of your products and a key requirement for GxP compliance. This is necessary not only for your facility, equipment, products, and processes but also for your computer systems. We focus here on computer systems validation.
Computerized systems and software validation (CSV) provides evidence that your systems are compliant with current regulations and are suitable for their intended purpose. You want to proactively perform CSV to ensure that your systems do what you intend, maintain data integrity, and meet regulatory agency requirements. Your computer systems should protect against: damage, shutdowns, distorted research results, product and sample loss, unstable conditions, and any other bad outcome you can forecast.
Once you install and validate a computer system, you need to keep its hardware and software updated. You need to perform validation studies to show that these updates to hardware and software maintain the validated state of your computer system. These continuous validation measures enable you to avoid errors in computer systems that “magically appear” after software upgrades or hardware changes.
Also, you want to consider your computer system validation when you start a new product or upgrade an existing product. Ask the question, “Do we have evidence that the computer system will work for this new product or upgrade, etc.?” If your answer is No, consider validating your computer system for this change. Then you’re ready for a running start!
PSC Biotech can provide you the highest quality CSV services on any scale. Our Computer System Validation experts, experience, and processes prevent overlooking small details and help you smoothly implement robust validation procedures. Contact us now for tailored computer systems validation professional services consulting!