Compliance Group

Amid 2020, quality assurance leaders in the pharmaceutical, medical device, and other FDA-regulated industries highlighted compliance and production as part of their quality goals. Maintaining consistent compliance has remained part of the top three challenges the industry has been experiencing. How can firms in the life science industry overcome these challenges?   Software Quality Assurance   is the key industry trend and has many benefits in preventing mistakes to ensure compliance and patient safety. To summarize, software validation has been a requirement by the FDA since 1997. Software  Quality Assurance  (SQA )  is the set of activities that ensure processes, procedures as well as standards are suitable for the project and implemented correctly Furthermore, pharmaceutical and medical device companies may be one of the same. Today, many companies in the industry are still being audited and fined at high costs for similar but different compliant regulated i...

Errors are usually a part of any process, action, or activity. There is always a percentage of error that happens. The practice must be to refine it and bring the errors down as low as humanly possible.    To adhere with industry regulations and to remain compliant with various policies, quality processes of organizations have multiple checks and internal policies in place to address the non-compliances and errors that occur during the lifecycle of manufacturing a product. The focus of these processes is to address the errors, analyze them, fix them and ensure that they do not occur again.    Often during this process, the regulatory burden makes it difficult for quality process individuals to provide their complete focus to solving the errors in a way that they are traceable backward, permanently fixed, and provide insights about any matters that need to be addressed immediately.   One of the most talked-about and feared issues in a quality process is...