Akra | Software As a Medical Device ( SaMD)

 The life sciences industry is undergoing a massive digital transformation. From drug discovery to clinical trials and regulatory submissions, software plays a critical role in enabling efficiency, accuracy, and compliance. However, with the rise of cloud computing and global collaboration, traditional validation approaches are struggling to keep pace. This is where cloud-native validation emerges as the future of life sciences software. 1. The Challenge with Traditional Validation For years, life sciences organizations have relied on static, manual, and document-heavy validation processes to meet regulatory requirements like 21 CFR Part 11 , Annex 11 , and GxP compliance . While effective in ensuring quality, this approach has several drawbacks: Time-consuming : Manual documentation and testing cycles slow down product releases. Resource-intensive : Validation often requires dedicated teams and long lead times. Inflexible : Updates to cloud applications or SaaS platfo...

  The healthcare industry is undergoing a massive digital transformation. From telemedicine to AI-driven diagnostics and wearable devices, digital health solutions are revolutionizing patient care. However, with innovation comes responsibility—particularly the responsibility to ensure compliance with strict healthcare regulations. Non-compliance not only leads to regulatory fines but also jeopardizes patient trust and data security. This makes digital healthcare compliance one of the most critical priorities for healthtech companies, hospitals, and startups worldwide. In this blog, we’ll explore: The biggest challenges in digital healthcare compliance. The impact of non-compliance on organizations. Actionable strategies to overcome these challenges. 🌍 Why Compliance Matters in Digital Healthcare Digital healthcare platforms handle sensitive patient data , including electronic health records (EHRs), test results, prescriptions, and personal identifiers. To protect...

 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...

                                            End-to-End Software Validation: From Development to Deployment with Akra.ai In today’s digitally regulated healthcare environment, software compliance is no longer an afterthought—it is the backbone of product credibility, safety, and market acceptance. At Akra.ai , we understand that end-to-end software validation is not just a regulatory requirement, but a strategic advantage. Our platform ensures full lifecycle validation, from the earliest stages of software development to real-time deployment, optimizing time-to-market while staying fully compliant with international standards such as FDA 21 CFR Part 11, EU MDR, ISO 13485 , and GxP guidelines. 🔍 What Is End-to-End Software Validation? End-to-end software validation refers to the comprehensive process of evaluating and documenting that a software system meets its intended u...

  As the healthcare industry undergoes a digital transformation, software as a medical device (SaMD) and embedded software in medical devices face increasing regulatory scrutiny. The EU Medical Device Regulation (EU MDR) and the FDA’s 21 CFR Part 820 and Part 11 provide the foundational frameworks for software validation. However, navigating these two sets of regulations can be daunting for manufacturers, especially those bringing products to both European and U.S. markets. This blog provides a comprehensive roadmap for software validation that ensures regulatory compliance , product quality , and patient safety across both jurisdictions. 📌 Understanding Software Validation: Why It Matters Software validation is not just a box-ticking exercise — it ensures the software performs consistently , meets user needs , and does not compromise clinical outcomes or patient safety . For regulatory bodies like the FDA and EU MDR , validation is mandatory and closely tied to the pr...