As defined by the FDA, software validation is the confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the requirements implemented through software can be consistently fulfilled. The main benefits of software validation include regulatory compliance, system reliability which allows a system to function as expected, reduction of the overall cost of maintaining quality, and faster scaling of a facility from pilot to manufacturing level helping to ensure that technicians are following all procedures as intended. Different types of validation include GAMP5 and GAMP4 level validation, user acceptance testing, and potentially a validation addendum being performed during a version upgrade. GAMP5 stands for Good Automated Manufacturing Practice. It is primarily used to leverage the vendors documentation and is the most common approach. GAMP4 is used to validate the entire system which is more intensive and not always required. Vendors will typically perform a GAMP4 level validation themselves, before making the product commercially available. The User Acceptance Testing approach is mostly used by those who are not regulated by the FDA and want to ensure that their workflows are satisfied using the system. Life Sciences, Pharmaceuticals, Medical Device Manufacturing and FDA-regulated Service Companies are all industries that typically require software validation to help ensure system reliability. Within these industries, a validation workflow needs to be put in place. Depending on the industry, there is a standard approach to validation that is used, which is further tailored based on the User Requirements of the client. Software validation can either be performed internally by a client’s quality team, or by or leveraging the vendor who provides the software. Taking the internal validation approach will require your own internal resources, expertise, and quality assurance team. This typically results in the project timeline to average longer than it would with a vendor. By working with a vendor, the client will have documentation readily accessible, a team of dedicated resources to lead you through this process, and typically shortens the over project length. Both approaches can lead to a successful validation, it simply depends on the company’s time, resources and expertise. Watch the replay of the Prime Technologies webinar where Robert Goss, Training Manager, and Rob Efford, Product & Customer Support Manager, talk about the importance of software validation, industries that are required to perform a validation, different types of validation, and the process of a validation. In addition, watch to learn more about the difference of working with a software vendor vs. performing validations internally. Watch the webinar here. Robert Goss has assisted companies in the process management world for more than six years and is respected for his expertise in the area of highly regulated industries. He recognizes the benefits of software validation and works to ensure dedicated resources are readily accessible in the validation process for clients. Rob Efford has worked with Prime’s Clients since 2004. Rob is a software validation specialist and is a certified ProCal subject matter expert. Rob works with customers to provide training in a wide range of industries.
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