One of the more difficult problems associated with the introduction of cloud computing is a constant need for software validation of platform software changes.
Many of Polarion’s clients use our software in the verification and validation (V&V) of product software, but equally important, our product is very well suited for onboarding what the Food and Drug Administration (FDA) terms “Automated Processes” as defined in 21 CFR §820.70(i).
These are systems developed for “When computers or automated data processing systems are used as part of production or the quality system, ...”. Examples include Product Life Management (PLM), Enterprise Resource Planning (ERP), custom production applications, and in some cases even the company web site if it is used for dissemination of company documentation to customers.
Specific requirements for validation of software used in any part of the device production process, or any part of the quality system must be validated for its intended use. The FDA has published guidance to assist in understanding the application of law. A copy is available here (PDF).
When using a Software as a Service (SAAS) model system, software is upgraded automatically, placing significant pressure on the IT department to perform - and approve the requisite changes. The workload on IT is significant, and system shut down for any significant time is unacceptable.
This means a mature software validation system is needed for automation and standardization of the software validation processes. Sometimes when a company does system software validation it will employ the structure typically used for process validation, i.e. IQ/OQ/PQ or Installation Qualification, Operational Qualification and Performance Qualification.
While the vernacular is useful in describing some of the components of a validation plan, more typically system validation will follow the product V&V framework. In the end, validation must provide, “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”
If management of the complexities is an ongoing problem in your organization, perhaps it’s time to consider Polarion as a solution. Polarion is a mature system which provides the structure for creation of user needs, requirements, risk management, traceability, and project workflows to automate many of the complex tasks common in onboarding system software in a regulated environment.
Written By: Laurence Sampson
To learn more, please click the banner to read: How to Achieve FDA 21 Part 820 Compliance with Polarion