Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.
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Data integrity issues have plagued the pharma industry since its inception. Blockchain, with its potential to assist in processes from product serialization to data flow tracking, could be the best solution yet.
Bringing design and quality assurance processes together earlier in the device development process can reduce costs and nonconformances, while improving outcomes.
As COVID-19 sweeps the globe, it’s becoming increasingly difficult for medical device leaders to navigate the arising challenges and prepare for the future.
The report also found that medical device companies are taking “huge gambles” in the area of risk management.
How much do you know about this standard? Review the results.
A guide to how and why QMS software helps medical technology companies.
Failure to provide records during an inspection will undoubtedly lead to a warning letter.