James Shore and Roxana Rosales04.01.20
Congratulations, you were able to get approval for the electronic quality management system (eQMS) you’ve been dreaming about, which is going to take your quality system to the next level. Now the fun begins—validating the software. This article is intended to walk you through the basics of what to do next as well as what to watch out for and what to avoid.
Why Validate?
Following are several specific requirements for reference in case your management asks why validation activities are necessary. From a regulatory requirement, the top four cited are:
This article is featured in the MPO eBook "Managing Medtech Manufacturing: Succeeding Through Software." Click here to download the eBook and finish reading this article.
Why Validate?
Following are several specific requirements for reference in case your management asks why validation activities are necessary. From a regulatory requirement, the top four cited are:
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on Jan. 11, 2002: “Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturer’s quality system.”
- FDA 21 CFR 820 Quality System Regulations - 21 CFR Part 820.70(i): “…the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance.”
- ISO 13485:2016(E) Section 4.1.6 establishes: “The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application. The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software.”
- 21 CFR Part 11: “In the event that these systems have associated electronic records or signatures, they are subject to the Electronic Records; Electronic Signatures regulation.”
This article is featured in the MPO eBook "Managing Medtech Manufacturing: Succeeding Through Software." Click here to download the eBook and finish reading this article.
