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FDA Compliance in Software Development: Cases Where Poor Software Quality Led to Costly FDA Rejections
- Poor software quality has become a contributing factor to costly FDA rejections in drug development, leading to delays and financial losses for companies.
- Regulatory rejections can occur due to various reasons, including insufficient clinical evidence, manufacturing issues, incomplete applications, missing data, and safety concerns.
- Software quality encompasses applications, programming environments, languages, and tools used in processing clinical data, drawing increased regulatory scrutiny.
- GxP compliance in software development is crucial for a smooth transition to open-source technologies, aiming to avoid FDA rejections caused by software quality issues.
- Common reasons for FDA rejections include insufficient clinical evidence, manufacturing and quality concerns, incomplete applications, missing data, and safety issues.
- Pharmaceutical companies using programming languages like R or Python are evaluated by the FDA on compliance with software standards for data analysis and reporting.
- Cases like Applied Therapeutics losing three-quarters of its valuation after a devastating FDA rejection highlight the significant impact of software-related deficiencies.
- FDA inspections, including pre-approval, routine GMP, for-cause, follow-up, Bioresearch Monitoring, post-market, and foreign inspections, play a vital role in upholding regulatory standards.
- Real-world FDA inspection reports reveal software-related compliance issues such as software bugs, security flaws, lack of validation, missing audit trails, and inadequate access controls.
- Appsilon assists companies in achieving GxP compliance by offering services like compliance audits, building compliant dashboards, and guiding pharma and life sciences organizations through regulatory requirements.
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