Claire Mc Cluskie has worked within Ideagen’s life sciences team for over three years.During that time she has built a deep understanding of the industry demands and requirements, particularly in the topics of validation and data integrity.ISO13485 has always implicitly implied that software applications supporting the design, development and quality management system (QMS) processes require to be validated.
However, the validation requirements of the guidance are specific to your intended use of the application and the uniqueness of your configuration.
Thus any software that you decide to use requires to be validated in the context of how it supports your company’s operations, practices and requirements. Do I have to test all the functions of the software I choose? Again, referring our own Q-Pulse software, with our validated offering our validation partner Compliance Path performs a full third party independent validation of all available functions.
Software validation can be an ambiguous subject within the industry and questions are arising around the associated regulatory and operational obligations for medical device companies following the updated ISO guidelines. Per Section 4.16 of the standard, this means any application that is being used to support the development of, or maintenance of, a medical device.
Within this feature, I look to address some of the direct questions I am seeing from clients in the medical device industry and hopefully clarify how software providers, such as ourselves at Ideagen, can support medical device organisations with the transition to ISO 13416 and their validation requirements. Any application that falls under those areas requires validation. ISO 13416 states more explicit requirements for software validation for different applications, how does this impact our compliance requirements?
Revalidation occurs when an updated version of the software you choose is released and you choose to install it.
Typically, revalidation is a short process that simply focuses on new functionality and checks any potential impact on functionality from the previous version. Can a validated e QMS reduce the risk to my business?
Yes, validating your e QMS provides an assurance of secure data, audit logs and increases the integrity of your record keeping and supplier quality processes.
As mentioned earlier, the purpose of this article is to try and answer some of the frequent questions I am faced with on a day-to-day basis from our clients operating in Life Science.
Aligning her knowledge of the industry and Ideagen’s products and services to the business needs of the industry is a key objective of her role.