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FDA Compliance in Software Development: Cases Where Poor Software Quality Led to Costly FDA Rejections
- Pharmaceutical companies invest significant time and money in drug development, making FDA rejections costly and detrimental for both finances and patient care.
- Regulatory rejections can stem from various reasons, with poor software quality emerging as a crucial but often overlooked factor in recent years.
- Software quality encompasses applications, programming environments, languages, and data processing tools, with regulatory bodies increasingly scrutinizing compliance in this realm.
- GxP compliance is essential for smooth transitions to new technologies like open-source tools; understanding cases of software quality issues leading to FDA rejections is key to prevention.
- Common reasons for FDA rejections include insufficient clinical evidence, manufacturing and quality concerns, incomplete applications, and safety issues, all of which can be impacted by software quality.
- The FDA closely examines software tools and methodologies used in data analysis, clinical trials, and regulatory submissions, emphasizing the importance of compliance in software development.
- Poor software quality can result in devastating FDA rejections, as evidenced by cases like Applied Therapeutics losing three-quarters of its valuation due to clinical application deficiencies.
- FDA inspections, including pre-approval, routine GMP, for-cause, follow-up, BIMO, post-market, and foreign inspections, are conducted to verify compliance and assess manufacturing processes.
- Publicly available FDA inspection reports highlight software-related compliance issues such as software bugs, security flaws, inadequate validation processes, lack of access controls, and missing documentation.
- Appsilon helps companies achieve GxP compliance by offering services such as compliance audits, building compliant Shiny dashboards in R and Python, and guiding through FDA and EMA submissions.
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