Software Validation Procedures

FDA’s ‘General Principles of Software Validation’ outlines several guidelines that industries should consider for software validation.  Especially for medical device and pharmaceutical industries, meeting these stringent rules is of utmost importance to survive in the large pool of manufacturers and reduce time to market.

ADB Consulting’s comprehensive software validation procedures have been designed keeping in mind these guidelines to ensure that the software product meets its pre-determined specifications and comply with the regulations. Devices categorized as class II and III, as well as some class I devices are subjected to design controls and hence we plan strategic procedures to serve the validation needs of all three kinds of medical devices with software type as follows:

·         Software used as a part, component, or accessory of a medical device

·         Software that itself is a medical device (e.g., blood establishment software)

·         Software used in the production of a medical device (e.g., PLCs)

Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history). 


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