Akra | Software As a Medical Device ( SaMD)

 In today’s fast-paced digital health and life sciences environment, organizations face a dual challenge: embracing the flexibility of Agile methodologies while maintaining rigorous GxP (Good Automated Manufacturing Practices) compliance. Traditional software validation models, based on waterfall processes, often clash with the iterative nature of Agile. However, with the right framework, it is not only possible—but highly effective—to bridge the two. Understanding GxP in Software Validation GxP guidelines refer to good practice regulations and standards across the pharmaceutical, biotechnology, and medical device sectors. These include: Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) Good Clinical Practices (GCP) In regulated industries, any software that impacts product quality or patient safety must be validated to ensure it performs as intended. This process is governed by regulatory frameworks like FDA 21 CFR Part 11 , EU Annex 11 , and IS...